Crf Template by uzz16582

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									              UCL CRF Template – Instructions
This is version 1, dated 02/03/2010 of the UCL CRF Template, please check our website
to ensure you are using the most up to date version:
www.ucl.ac.uk/joint-rd-unit/clinical_trials_unit/SOPs

Please use this template as the basis for the Case Report Forms for your CTIMP. It should be used in
conjunction with the JBRU Guide JBRU/INV/G01/00 Guide For the Design, Use and Completion of
Paper Case Report Forms (CRFs). Using your protocol, please add or delete pages as required and
ensure that all visits and end points are covered as well as any data defined in the protocol is covered in
this CRF. It is also important that you ensure that you do not collect any data which is not in your
protocol, for instance if you are not collecting alcohol and smoking history at screening you should
delete this page.

The following pages should be included in every CRF:
Front page
CRF Completion Instructions
Demographics (including informed consent details, but the ethnicity is not compulsory – if you do record
ethnicity these are the categories provided in the 2001 Census and should be used)
Inclusion and Exclusion Criteria
Eligibility Review and sign off
Trial Medication Administration (choose the appropriate method of administration, or add your own)
Study completion
Adverse events table (Note that Phase I trials should complete the Serious Adverse Events log with all
Adverse Events recorded)
Concomitant Medications table
Principal Investigator’s sign off

As well as the compulsory forms, this template includes a number of elective forms (for instance
laboratory results); these are by no means exhaustive and cannot cover every possible investigation,
you should design these study specific forms yourself.

If you will be repeating investigations if they are out of range (for instance blood pressure or bloods),
please add pages for these, clearly marking them ‘repeats’.

We have used ‘Subject No.’ throughout this template, if you have used different terminology (e.g.
Screening No., Patient No., Enrolment No. etc.) in your protocol you should amend this template to
maintain consistency.

Text given in blue should be completed before printing the CRF. Text given in green are for options or
‘as required’ details – please use or delete as appropriate. Please change the colour of all the text to
black and white before printing.

Please note that the template has been broken in to sections so that different information can be added
to the headers and footers as appropriate; note you may need to enter the information in to the header or
footer of each section so that it appears on every page.
Section 1: Cover page and instructions
Section 2: Screening (Screening No. can be added to the header in this section if required instead of
Subject No.)
Section 3: Post randomisation/enrolment visits
Section 4: AEs/ConMeds pages (landscape)
Section 5: PI sign off (portrait again)

  This instruction page should be deleted once you have designed
                             your CRF.

SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                             Page 1 of 30
               CASE REPORT FORM
                                               Trial Title
                                         Short Title/Acronym



Chief Investigator:
Sponsor Number: XX/XXXX
EudraCT Number: XXXX-XXXXXX-XXX
Name of site:
CRF Version Number: X, XX/XXX/XXXX




Patient Initials                                          Subject No.

Screening No.                                             Centre No.




SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                 Page 2 of 30
                                 CRF Completion Instructions
General
Complete the CRF using a black ballpoint pen and that all entries are complete and legible.

Avoid the use of abbreviations and acronyms.

The CRF should be completed as soon as possible after the scheduled visit.

Ensure that the header information (i.e. subject’s initials and ID number) is completed consistently
throughout the CRF. Missing initials should be recorded with a dash (i.e. D-L)

If a subject prematurely withdraws from the trial a single line must be drawn across each uncompleted
page.

Ensure that all fields are completed on each page
               If a test was Not Done record ND in the relevant box(es)
               Where information is Not Known write NK in relevant box(es)
               Where information is not applicable write NA in the relevant box(es)

The Principal Investigator is responsible for the accuracy of the data reported on the CRF. The PI must
sign and date the Principal Investigator’s Sign Off page to certify accuracy, completeness and legibility of
the data reported in the CRF.

Medications should be recorded using the generic name whenever possible excepting combination
products which will be recorded using the established trade name.

Verbatim Adverse Event terms should be recorded as the final diagnosis whenever possible.

Complete all dates as day, month, year i.e. 13/NOV/2008. Partial dates should be recorded as
NK/NOV/2008

All times are to be recorded in 24 hour format without punctuation always using 4-digits; i.e. 0200 or
2130. Midnight is recorded as 0000.

Weights should be recorded to the nearest 0.1 kg

CRF Footer section
The ‘completed by’ Name must be legible and CRFs should only be completed by individuals on the
Site Delegation log, signed by the PI
Each CRF should be signed and dated by the person completing the form

Serious Adverse Events (SAEs)
SAEs should be faxed within 1 business day of the site being aware of the event to 020 7380 9937

Corrections to entries
If an error is made draw a single line through the item, then write the correct entry on an appropriate
blank space near the original data point on the CRF and initial and date the change
        Do NOT
               Obscure the original entry by scribbling it out
               Try to correct/ modify the original entry
               Use Tippex or correction fluid

Storage
The CRF documents should be stored in a locked, secure area when not in use where confidentiality can
be maintained. Ensure that they are separate to any other documents that might reveal the identity of
the subject.



SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                           Page 3 of 30
 < Short Title/Acronym>                                                  Sponsor
                                                                         No.
                                                                                     X X /          X X X X
Subject/Scr                           Patient                                Site
eening No.                                                                           Name
                                      Initials



                   VISIT 1 (SCREENING) DEMOGRAPHIC DATA
 Date of Assessment: __ __ / __ __ __ / __ __ __ __
                             (DD / MMM / YYYY)



 Participant Informed Consent:

 Date participant
                               __ __ / __ __ __ / __ __ __ __     Date of first trial-related   __ __ / __ __ __ / __ __ __ __
 signed written
                                    (DD / MMM / YYYY)             procedure:                         (DD / MMM / YYYY)
 consent form:


 Name of person taking informed consent: ____________________________________________




 Demographic Data:


                                       __ __ / __ __ __ / __ __ __ __
 Date of Birth:
                                            (DD / MMM / YYYY)


 Ethinicity:
 White              White British                White Irish                    White Other
                    White & Black                White & Black                                          Other mixed
 Mixed race                                                                     White & Asian
                    Caribbean                    African                                                background
 Asian or Asian                                                                                         Other Asian
                    Indian                       Bangladeshi                    Pakistani
 British                                                                                                background
 Black or Black
                    Caribbean                    African                        Black Other
 British
 Chinese or                                      Other          (please specify)
                    Chinese
 other ethnicity

 Sex:                            Male
                                 Female




 Completed by:
                  Name                                          Signature                                         Date


                  Name                                          Signature                                         Date
 SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                                      Page 4 of 30
 < Short Title/Acronym>                                       Sponsor
                                                              No.
                                                                          X X /            X X X X
Subject/Scr                         Patient                        Site
eening No.                                                                Name
                                    Initials



                    VISIT 1 (SCREENING) MEDICAL HISTORY

 Date of Assessment: __ __ / __ __ __ / __ __ __ __
                           (DD / MMM / YYYY)




 Has the patient had any relevant medical history?                No           Yes, Complete below

                                                                                                         Or tick if
                                                                  Start date          Stop date         ongoing at
         Condition / illness /surgical procedure              (DD/MMM/YYYY)          (DD/MMM/YYYY)      Screening
                                                                                                          Visit?


                                                             ____/_____/_____ ____/_____/_____


                                                             ____/_____/_____ ____/_____/_____


                                                             ____/_____/_____ ____/_____/_____


                                                             ____/_____/_____ ____/_____/_____


                                                             ____/_____/_____ ____/_____/_____


                                                             ____/_____/_____ ____/_____/_____


                                                             ____/_____/_____ ____/_____/_____


                                                             ____/_____/_____ ____/_____/_____


                                                             ____/_____/_____ ____/_____/_____


                                                             ____/_____/_____ ____/_____/_____


                                                             ____/_____/_____ ____/_____/_____


                                                             ____/_____/_____ ____/_____/_____




 Completed by:
                 Name                                 Signature                                         Date


                 Name                                 Signature                                         Date
 SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                             Page 5 of 30
 < Short Title/Acronym>                                       Sponsor
                                                              No.
                                                                             X X /         X X X X
Subject/Scr                         Patient                        Site
eening No.                                                                   Name
                                    Initials


                       VISIT 1 (SCREENING) PHYSICAL EXAM

 Date of Assessment: __ __ / __ __ __ / __ __ __ __
                           (DD / MMM / YYYY)



        Was Physical Examination performed?                           No           Yes, Complete below

                                                                          *If noted ABNORMAL, please provide
                                                             Not
              System              *Abnormal      Normal                      brief description and comment if
                                                            done
                                                                          clinically significant or not (CS/NCS)

 General Appearance


 Skin

 Eyes, Ears, Nose & Throat

 Head, Neck & Thyroid

 Heart

 Lungs

 Chest (including breasts)


 Abdomen


 Extremities


 Genitalia

 Anorectal

 Lymph Nodes

 Muscular-Skeletal


 Neurological

 Others




 Completed by:
                 Name                                 Signature                                       Date


                 Name                                 Signature                                       Date
 SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                           Page 6 of 30
 < Short Title/Acronym>                                         Sponsor
                                                                No.
                                                                             X X /              X X X X
Subject/Scr                        Patient                         Site
eening No.                                                                   Name
                                   Initials


                   VISIT 1 (SCREENING) VITAL SIGNS & ECG

 Were Vital Signs performed?                                No             Yes, Complete below


                                                                           __ __ / __ __ __ / __ __ __ __
 Date of Vital Signs:
                                                                                (DD / MMM / YYYY)



 Blood Pressure (supine) :                                        ___ ___ ___ / ___ ___ ___ mmHg



 Blood Pressure (standing) :                                      ___ ___ ___ / ___ ___ ___ mmHg



 Pulse:                 ____ ___ ___ beats/min



 Weight:                ___ ___ ___ . ___ kg                      Height:     ___ . ___ ___ m



 Oral Temperature:           ___ ___ . ___ °C




 Was an ECG performed?                                     No             Yes, Complete below

                                                                          __ __ / __ __ __ / __ __ __ __
 Date of ECG:                                                                  (DD / MMM / YYYY)




                                 Within normal limits



                                 Abnormal, NOT clinically significant
 The ECG is:

                                 Abnormal, clinically significant, please specify:

                                 _____________________________________________________________




 Completed by:
                 Name                                 Signature                                                Date


                 Name                                 Signature                                                Date
 SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                                    Page 7 of 30
 < Short Title/Acronym>                                        Sponsor
                                                               No.
                                                                            X X /           X X X X
Subject/Scr                        Patient                          Site
eening No.                                                                  Name
                                   Initials

                      VISIT 1 (SCREENING) HAEMATOLOGY

       Clinical Haematology Laboratory tests
                                                                       No         Yes, Complete below
                    performed?

                                                                      __ __ / __ __ __ / __ __ __ __
                    Date of Sample:
                                                                            (DD / MMM / YYYY)

                                                                      No         Yes, Complete below
 Was laboratory sample taken at different hospital
                                                                      Laboratory name / Location:
    to <insert investigator’s site lab name>?
                                                           __________________________________________


        HAEMATOLOGY                      Value               Unit            If parameter indicated as out of
                                                                             normal range on report, please
     Laboratory Parameter                                                      check if clinically significant:

              WBC                                                                      No          Yes

              RBC                                                                      No          Yes

               Hb                                                                      No          Yes

              HCT                                                                      No          Yes

              MCV                                                                      No          Yes

              MCH                                                                      No          Yes

              PLT                                                                      No          Yes

        NEUTROPHILS                                                                    No          Yes

        LYMPHOCYTES                                                                    No          Yes

         MONOCYTES                                                                     No          Yes

         EOSINOPHILS                                                                   No          Yes

          BASOPHILS                                                                    No          Yes

       RETICULOCYTES                                                                   No          Yes




 Completed by:
                 Name                                 Signature                                        Date


                 Name                                 Signature                                        Date
 SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                           Page 8 of 30
 < Short Title/Acronym>                                        Sponsor
                                                               No.
                                                                            X X /           X X X X
Subject/Scr                        Patient                          Site
eening No.                                                                  Name
                                   Initials

                        VISIT 1 (SCREENING) BIOCHEMISTRY

       Clinical Biochemistry Laboratory tests
                                                                       No         Yes, Complete below
                     performed?

                                                                      __ __ / __ __ __ / __ __ __ __
                      Date of Sample:
                                                                            (DD / MMM / YYYY)

                                                                      No         Yes, Complete below
   Were laboratory samples taken at different
 hospital other than <insert investigator’s site lab                  Laboratory name / Location:
                      name>?
                                                           __________________________________________


        BIOCHEMISTRY                     Value               Unit            If parameter indicated as out of
                                                                             normal range on report, please
     Laboratory Parameter                                                      check if clinically significant:

              SODIUM                                                                   No          Yes

          POTASSIUM                                                                    No          Yes

              CHLORIDE                                                                 No          Yes

        BICARBONATE                                                                    No          Yes

               UREA                                                                    No          Yes

          CREATININE                                                                   No          Yes

       TOTAL PROTEIN                                                                   No          Yes

       TOTAL BILIRUBIN                                                                 No          Yes

              ALBUMIN                                                                  No          Yes

              ALK PHOS                                                                 No          Yes

                ALT                                                                    No          Yes

                AST                                                                    No          Yes

              CALCIUM                                                                  No          Yes




 Completed by:
                 Name                                 Signature                                        Date


                 Name                                 Signature                                        Date
 SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                           Page 9 of 30
 < Short Title/Acronym>                                        Sponsor
                                                               No.
                                                                            X X /           X X X X
Subject/Scr                        Patient                          Site
eening No.                                                                  Name
                                   Initials

              VISIT 1 (SCREENING) < INSERT ASSESSMENT>

   Clinical <insert assessment> Laboratory tests
                                                                       No         Yes, Complete below
                     performed?

                                                                      __ __ / __ __ __ / __ __ __ __
                   Date of Sample:
                                                                            (DD / MMM / YYYY)

                                                                      No         Yes, Complete below
 Was laboratory sample taken at different hospital
                                                                      Laboratory name / Location:
    to <insert investigator’s site lab name>?
                                                           __________________________________________


   <INSERT ASSESSMENT>                   Value               Unit            If parameter indicated as out of
                                                                             normal range on report, please
     Laboratory Parameter                                                      check if clinically significant:

                                                                                       No          Yes

                                                                                       No          Yes

                                                                                       No          Yes

                                                                                       No          Yes

                                                                                       No          Yes

                                                                                       No          Yes

                                                                                       No          Yes

                                                                                       No          Yes

                                                                                       No          Yes

                                                                                       No          Yes

                                                                                       No          Yes

                                                                                       No          Yes

                                                                                       No          Yes




 Completed by:
                 Name                                 Signature                                        Date


                 Name                                 Signature                                        Date
 SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                          Page 10 of 30
 < Short Title/Acronym>                                                     Sponsor
                                                                            No.
                                                                                      X X /         X X X X
Subject/Scr                               Patient                             Site
eening No.                                                                            Name
                                          Initials


                VISIT 1 (SCREENING) SCREENING CONCOMITANT
                                MEDICATIONS

 Date of Assessment: __ __ / __ __ __ / __ __ __ __
                                 (DD / MMM / YYYY)


   Has the participant taken any concomitant medications at
screening or <insert time frame as specified in protocol> prior to                      No         Yes, Complete below
                           screening?
                                 Reason for use                                                                            Or tick if
                                 (Medical History                                                                          ongoing
           Medication                                Dose and     Freque-          Start Date        Stop Date
                                diagnosis or other                                                                            at
     (Record Generic or name)                          units      ncy           (DD/MMM/YYYY)      (DD//MMM/YYY)
                                   reason, e.g.                                                                           Screening
                                   Prophylaxis)                                                                              Visit



1.
                                                                              ____/_____/_____   ____/_____/_____


2.
                                                                              ____/_____/_____   ____/_____/_____


3.
                                                                              ____/_____/_____   ____/_____/_____


4.
                                                                              ____/_____/_____   ____/_____/_____


5.
                                                                              ____/_____/_____   ____/_____/_____


6.
                                                                              ____/_____/_____   ____/_____/_____


7.
                                                                              ____/_____/_____   ____/_____/_____


8.
                                                                              ____/_____/_____   ____/_____/_____


9.
                                                                              ____/_____/_____   ____/_____/_____


10.
                                                                              ____/_____/_____   ____/_____/_____




 Completed by:
                       Name                                     Signature                                          Date


                       Name                                     Signature                                          Date
 SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                                    Page 11 of 30
 < Short Title/Acronym>                                         Sponsor
                                                                No.
                                                                            X X /          X X X X
Subject/Scr                         Patient                        Site
eening No.                                                                  Name
                                    Initials

         VISIT 1 (SCREENING) SMOKING / ALCOHOL STATUS

 Date of Assessment: __ __ / __ __ __ / __ __ __ __
                           (DD / MMM / YYYY)




                   Has the participant ever smoked?           No           Yes, Complete below


                                Participant’s average daily use:
                                - Number of cigarettes : ___ ___
                                - Number of cigars : ____ ___
       Current Smoker
                                - Number of pipes : ___ ___

                                Smoked for ___ ___ years

                                Smoked for ___ ___ years

                                Date when smoking ceased: __ __ / __ __ __ / __ __ __ __
                                                                  (DD / MMM / YYYY)


       Former smoker            When smoking, participant’s average daily use:
                                - Number of cigarettes : ___ ___
                                - Number of cigars : ____ ___
                                - Number of pipes : ___ ___




 Participant’s alcohol consumption

 Participant’s average consumption per <insert time frame stated in protocol>:
 - Number of units of wine : ___ ___
 - Number of units of beer : ____ ___
 - Number of units of spirits : ___ ___
 (see protocol for definition of units)




 Completed by:
                 Name                                 Signature                                      Date


                 Name                                 Signature                                      Date
 SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                         Page 12 of 30
 < Short Title/Acronym>                                       Sponsor
                                                              No.
                                                                         X X /       X X X X
Subject/Scr                         Patient                       Site
eening No.                                                               Name
                                    Initials
                 VISIT 1 (SCREENING) INCLUSION CRITERIA

 Date of Assessment: __ __ / __ __ __ / __ __ __ __
                           (DD / MMM / YYYY)


 The following criteria MUST be answered YES for participant to be included
                                                                                      Yes          No
 in the trial (except where NA is appropriate):

  1.

  2.

  3.

  4.

  5.

  6.

  7.

  8.

  9.

 10.

  If any of the above criteria is answered NO, the participant is NOT eligible for the trial and must not
      be included in the study. Please list reason(s) for ineligibility for screen failure on Participant
                                          Eligibility Review page.




 Completed by:
                 Name                                 Signature                                  Date


                 Name                                 Signature                                  Date
 SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                    Page 13 of 30
 < Short Title/Acronym>                                       Sponsor
                                                              No.
                                                                         X X /        X X X X
Subject/Scr                         Patient                       Site
eening No.                                                               Name
                                    Initials


                 VISIT 1 (SCREENING) EXCLUSION CRITERIA

 Date of Assessment: __ __ / __ __ __ / __ __ __ __
                           (DD / MMM / YYYY)


 The following criteria MUST be answered NO for the participant to be included in
                                                                                          Yes        No
 the trial:

  1.

  2.

  3.

  4.

  5.

  6.

  7.

  8.

  9.

 10.

  If any of the above criteria is answered YES, the participant is NOT eligible for the trial and must not
      be included in the study. Please list reason(s) for ineligibility for screen failure on Participant
                                          Eligibility Review page.




 Completed by:
                 Name                                 Signature                                  Date


                 Name                                 Signature                                  Date
 SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                     Page 14 of 30
 < Short Title/Acronym>                                            Sponsor
                                                                   No.
                                                                             X X /     X X X X
Subject/Scr                           Patient                         Site
eening No.                                                                   Name
                                      Initials



      VISIT 1 (SCREENING) PARTICIPANT ELIGIBILITY REVIEW

 End of Screening Visit Checklist:
                                                                                                Yes      No
 1.     Does the participant satisfy the inclusion and exclusion criteria to date?

 2.     Have all Screening Visit procedures been completed?

 3.     Have the Medical History and Concomitant Medication pages been
        completed?

 4.     Is the participant still willing to proceed in the trial?




 Participant’s eligibility Investigator Sign-Off:

 Is the participant eligible to take part in the Clinical Trial?                        Yes


 PI’s Signature: __________________ Date : __ __ / __ __ __ / __ __ __ __                 No, Please give
                                                                                     reason for screen
                                             (DD / MMM / YYYY)
                                                                                     failure below


 P’s Name:        __________________
 Reason(s) for screen failure:
 1.

 2.

 3.




 Completed by:
                  Name                                    Signature                               Date


                  Name                                    Signature                               Date
 SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                      Page 15 of 30
< Short Title/Acronym>                                       Sponsor
                                                             No.
                                                                        X X /          X X X X

Subject                           Patient                        Site
No.
                                                                        Name
                                  Initials



                        VISIT <INSERT VISIT No.> / NAME>
                         RANDOMISATION/ENROLMENT

Participant Randomisation/Enrolment



       Participant study Number allocated:                                ____ ____ ____



                                                                   __ __ / __ __ __ / __ __ __ __
        Date of Randomisation/Enrolment:
                                                                        (DD / MMM / YYYY)




Completed by:
                Name                                 Signature                                      Date


                Name                                 Signature                                      Date
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                       Page 16 of 30
< Short Title/Acronym>                                           Sponsor
                                                                 No.
                                                                            X X /   X X X X

Subject                            Patient                           Site
No.
                                                                            Name
                                   Initials




                   VISIT X <INSERT VISIT NAME> CHECKLIST

                            __ __ / __ __ __ / __ __ __ __
Date of Visit:
                                 (DD / MMM / YYYY)




Visit Checklist:

                                                                                          Yes       No

      Have there been any new Adverse Events?
 1.
      (If yes, please record in Adverse Events Log)

      Have there been any changes in Concomitant Medications?
 2.
      (If yes, please record in Concomitant Medications Log)

      Add further assessments required at each visit, amend the following pages to fit
 3.
      your requirements


 4.




Completed by:
                 Name                                    Signature                           Date


                 Name                                    Signature                           Date
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                  Page 17 of 30
< Short Title/Acronym>                                        Sponsor
                                                              No.
                                                                         X X /        X X X X

Subject                            Patient                        Site
No.
                                                                         Name
                                   Initials

            VISIT X <INSERT VISIT NAME> PHYSICAL EXAM

Date of Assessment: __ __ / __ __ __ / __ __ __ __
                          (DD / MMM / YYYY)



  Was Physical Examination performed?                             No       Yes, Complete below

                                                             *If CHANGED from previous examination or
                                          Not         Not    new abnormality noted, please provide brief
        System           *Changed
                                        Changed      done        description and comment if clinically
                                                                     significant or not (CS/NCS).

General Appearance

Skin

Eyes, Ears, Nose &
Throat

Head, Neck &
Thyroid

Heart

Lungs

Chest (including
breasts)

Abdomen

Extremities

Genitalia

Anorectal

Lymph Nodes

Muscular-Skeletal

Neurological


Others




Completed by:
                 Name                                 Signature                                  Date


                 Name                                 Signature                                  Date
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                     Page 18 of 30
< Short Title/Acronym>                                         Sponsor
                                                               No.
                                                                            X X /              X X X X

Subject                           Patient                         Site
No.
                                                                            Name
                                  Initials



          VISIT X <INSERT VISIT NAME> VITAL SIGNS & ECG

Were Vital Signs performed?                                No             Yes, Complete below


                                                                          __ __ / __ __ __ / __ __ __ __
Date of Vital Signs:
                                                                               (DD / MMM / YYYY)



Blood Pressure (supine) :                                        ___ ___ ___ / ___ ___ ___ mmHg



Blood Pressure (standing) :                                      ___ ___ ___ / ___ ___ ___ mmHg



Pulse:                 ____ ___ ___ beats/min



Weight:                ___ ___ ___ . ___ kg                      Height:     ___ . ___ ___ m



Oral Temperature:           ___ ___ . ___ °C




Was an ECG performed?                                     No             Yes, Complete below

                                                                         __ __ / __ __ __ / __ __ __ __
Date of ECG:                                                                  (DD / MMM / YYYY)




                                Within normal limits



                                Abnormal, NOT clinically significant
The ECG is:

                                Abnormal, clinically significant, please specify:

                                _____________________________________________________________




Completed by:
                Name                                 Signature                                                 Date


                Name                                 Signature                                                 Date
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                                    Page 19 of 30
< Short Title/Acronym>                                        Sponsor
                                                              No.
                                                                        X X /            X X X X

Subject                                                        Site
                                  Patient VISIT X <INSERT VISIT N
No.
                                                                        Name
                                  Initials
                           > HAEMATOLOGY
                                     AME
             VISIT X <INSERT VISIT NAME> HAEMATOLOGY

      Clinical Haematology Laboratory tests
                                                                   No         Yes, Complete below
                   performed?

                                                                   __ __ / __ __ __ / __ __ __ __
                   Date of Sample:
                                                                        (DD / MMM / YYYY)

                                                                   No        Yes, Complete below
Was laboratory sample taken at different hospital
                                                                   Laboratory name / Location:
   to <insert investigator’s site lab name>?
                                                          __________________________________________


      HAEMATOLOGY                       Value               Unit         If parameter indicated as out of
                                                                         normal range on report, please
   Laboratory Parameter                                                    check if clinically significant:

             WBC                                                                    No         Yes

             RBC                                                                    No         Yes

              Hb                                                                    No         Yes

             HCT                                                                    No         Yes

             MCV                                                                    No         Yes

             MCH                                                                    No         Yes

             PLT                                                                    No         Yes

       NEUTROPHILS                                                                  No         Yes

       LYMPHOCYTES                                                                  No         Yes

          MONOCYTES                                                                 No         Yes

        EOSINOPHILS                                                                 No         Yes

          BASOPHILS                                                                 No         Yes

      RETICULOCYTES                                                                 No         Yes



Completed by:
                Name                                 Signature                                      Date


                Name                                 Signature                                      Date
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                       Page 20 of 30
< Short Title/Acronym>                                        Sponsor
                                                              No.
                                                                           X X /           X X X X

Subject                           Patient                          Site
No.
                                                                           Name
                                  Initials


             VISIT X <INSERT VISIT NAME> BIOCHEMISTRY

     Clinical Biochemistry Laboratory tests
                                                                      No         Yes, Complete below
                   performed?

                                                                     __ __ / __ __ __ / __ __ __ __
                   Date of Sample:
                                                                           (DD / MMM / YYYY)

                                                                     No         Yes, Complete below
Was laboratory sample taken at different hospital
                                                                     Laboratory name / Location:
   to <insert investigator’s site lab name>?
                                                          __________________________________________


       BIOCHEMISTRY                     Value               Unit            If parameter indicated as out of
                                                                            normal range on report, please
   Laboratory Parameter                                                       check if clinically significant:

           SODIUM                                                                     No          Yes

          POTASSIUM                                                                   No          Yes

          CHLORIDE                                                                    No          Yes

       BICARBONATE                                                                    No          Yes

            UREA                                                                      No          Yes

          CREATININE                                                                  No          Yes

      TOTAL PROTEIN                                                                   No          Yes

      TOTAL BILIRUBIN                                                                 No          Yes

           ALBUMIN                                                                    No          Yes

          ALK PHOS                                                                    No          Yes

             ALT                                                                      No          Yes

             AST                                                                      No          Yes

           CALCIUM                                                                    No          Yes



Completed by:
                Name                                 Signature                                        Date


                Name                                 Signature                                        Date
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                          Page 21 of 30
< Short Title/Acronym>                                        Sponsor
                                                              No.
                                                                           X X /           X X X X

Subject                           Patient                          Site
No.
                                                                            Name
                                  Initials

     VISIT X <INSERT VISIT NAME> <INSERT ASSESSMENT>

 Clinical <insert assessment> Laboratory tests
                                                                      No         Yes, Complete below
                   performed?

                                                                     __ __ / __ __ __ / __ __ __ __
                  Date of Sample:
                                                                           (DD / MMM / YYYY)

                                                                     No         Yes, Complete below

Was laboratory sample taken at different hospital                    Laboratory name / Location:
   to <insert investigator’s site lab name>?

                                                          __________________________________________


  <INSERT ASSESSMENT>                   Value               Unit            If parameter indicated as out of
                                                                            normal range on report, please
   Laboratory Parameter                                                       check if clinically significant:

                                                                                      No          Yes

                                                                                      No          Yes

                                                                                      No          Yes

                                                                                      No          Yes

                                                                                      No          Yes

                                                                                      No          Yes

                                                                                      No          Yes

                                                                                      No          Yes

                                                                                      No          Yes

                                                                                      No          Yes




Completed by:
                Name                                 Signature                                        Date


                Name                                 Signature                                        Date
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                          Page 22 of 30
< Short Title/Acronym>                                       Sponsor
                                                             No.
                                                                        X X /   X X X X

Subject                           Patient                        Site
No.
                                                                        Name
                                  Initials

VISIT X <INSERT VISIT NAME>< ASSESSMENT PERFORMED>

<Insert other assessments>




Completed by:
                Name                                 Signature                        Date


                Name                                 Signature                        Date
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                           Page 23 of 30
< Short Title/Acronym>                                         Sponsor
                                                               No.
                                                                              X X /         X X X X

Subject                           Patient                         Site
No.
                                                                              Name
                                  Initials

          VISIT X <INSERT VISIT NAME> TRIAL MEDICATION
                    ADIMINSTRATION/DISPENSING
<Insert name of trial medication> Administration
CHOOSE APPROPRIATE DOSING/DISPENSING TABLE FOR YOUR PROTOCOL
AND MODIFY AS REQUIRED
    Date of Dosing               Time of Dosing                 Dose           Comment ONLY if dose
   (DD/MMM/YYYY)                     (24 hr)              (including units)    delayed, interrupted, reduced
                                                                               or altered

 ____/_____/______           ____ ____:____ ____

 ____/_____/______           ____ ____:____ ____

                                                                                  Comment ONLY if dose
  Start date of dosing        Stop date of dosing               Dose
                                                                               delayed, interrupted, reduced
   (DD/MMM/YYYY)               (DD/MMM/YYYY)              (including units)
                                                                                         or altered


    ____/_____/_____             ____/_____/_____


    ____/_____/_____             ____/_____/_____
INFUSION
  Date of Infusion           Start time of        Stop time of infusion             Dose          Comment ONLY
  (DD/MMM/YYYY)                infusion                                       (including units)   if dose delayed,
                                                                                                  interrupted,
                                                                                                  reduced or
                                                                                                  altered

____/_____/______          ______:______             ______:______

____/_____/______          ______:______             ______:______
DISPENSING
Date of Dispensing IMP         Quantity Dispensed          <Daily> Dose        Comment ONLY if dose
   (DD/MMM/YYYY)                  (no. tablets/           (including units)    delayed, reduced or altered
                                 pens/patches)

  ____/_____/______
RETURNS (add to subsequent visit)
 Date of Returning IMP         Quantity Returned          Comment on compliance
   (DD/MMM/YYYY)                 (no. tablets/
                                pens/patches)

  ____/_____/______



Completed by:
                Name                                 Signature                                         Date


                Name                                 Signature                                         Date
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                            Page 24 of 30
< Short Title/Acronym>                                             Sponsor
                                                                   No.
                                                                               X X /            X X X X

Subject                           Patient                            Site
No.
                                                                               Name
                                  Initials

                                     TRIAL COMPLETION

                                                             Yes, Please provide date of last visit:

                                                                            __ __ / __ __ __ / 2 0 __ __
                                                                              (DD / MMM / YYYY)
Did participant complete the trial?
                                                             No, Please provide date of withdrawal and complete
                                                          below:

                                                                            __ __ / __ __ __ / 2 0 __ __
                                                                              (DD / MMM / YYYY)

Early Withdrawal: please tick most appropriate reason for participant not completing the trial:



   Adverse Events related: please state related AE: _______________________

   Participant’s decision, specify: __________________________

   Investigator’s decision, specify: __________________________

   Sponsor’s decision

   Lost to follow up

   Other, specify: __________________________




Completed by:
                Name                                 Signature                                             Date


                Name                                 Signature                                             Date
SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                                Page 25 of 30
 < Short Title/Acronym>                                            Sponsor
                                                                   No.
                                                                              X X /           X X X X

  Subject                                  Patient                     Site
  No.                                      Initials
                                                                              Name

                                                                     ADVERSE EVENTS LOG
                                                                                                                             Study Drug                        Relationship to
                                                                                     Serious?                   Severity                       Outcome          Study Drug
                                                                                     If serious,      Con-                     Action          0 - Resolved
                                                                                                                  0 - Mild                                         0 - Definitely
 AE             Event Name                            Start date     Stop date          please      comitant                     0 - None       1- Resolved
                                                                                                                 1- Mode-                                          1 - Probably
                                                                                                   Medication                1 - Temporarily
 No     (Please give Diagnosis if known)          (DD/MMM/YYYY)    (DD/MMM/YYYY)     completed
                                                                                                                    rate
                                                                                                                                               with sequelea       2 - Possibly
                                                                                       a JBRU                                   Interrupted        2 - Not
                                                                                                     given      2 - Severe                                          3 - Unlikely
                                                                                     SAE form                                2 - permanently      resolved       4 - Not related
                                                                                                                                 withdrawn
                                                                                                                                                               5 - Not assessable

                                                                                            No           No
  1                                               ____/____/____   ____/_____/____          Yes          Yes

                                                                                            No           No
  2                                              ____/_____/____   ____/_____/____          Yes          Yes

                                                                                            No           No
  3                                              ____/_____/____   ____/_____/____          Yes          Yes

                                                                                            No           No
  4                                              ____/_____/____   ____/_____/____          Yes          Yes

                                                                                            No           No
  5                                              ____/_____/____   ____/_____/____          Yes          Yes

                                                                                            No           No
  6
                                                 ____/_____/____   ____/_____/____          Yes          Yes
I have reviewed the AEs on this log and have assessed them for seriousness, causality, severity and outcome and confirm that, to the best of my knowledge, it
accurately reflects the study information obtained for this participant
 PI signature _______________________________ _________________ Date:_________________________                      Please check box if this is the last page used

 Completed by:
                  Name                                               Signature                                                       Date


                  Name                                               Signature                                                        Date
 SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                                                                                             Page 26 of 30
 < Short Title/Acronym>                                                Sponsor
                                                                       No.
                                                                                 X X /           X X X X

  Subject                                  Patient                        Site
  No.                                      Initials
                                                                                 Name
                                                       ADVERSE EVENTS LOG (CONTINUATION PAGE)
                                                                                                                                 Study Drug                           Relationship to
                                                                                         Serious?                   Severity                        Outcome            Study Drug
                                                                                         If serious,   Concomita                   Action
                                                                                                                      0 - Mild                       0 - Resolved         0 - Definitely
 AE             Event Name                             Start date        Stop date         please          nt                        0 - None
                                                                                                                     1- Mode-                        1- Resolved          1 - Probably
                                                                                                       Medication                1 - Temporarily
 No     (Please give Diagnosis if known)          (DD/MMM/YYYY)        (DD/MMM/YYYY)     completed
                                                                                                                        rate                        with sequelea         2 - Possibly
                                                                                           a JBRU                                   Interrupted
                                                                                                         given      2 - Severe                     2 - Not resolved        3 - Unlikely
                                                                                         SAE form                                2 - permanently
                                                                                                                                                                        4 - Not related
                                                                                                                                     withdrawn
                                                                                                                                                                      5 - Not assessable

                                                                                                No           No
 __                                                   ____/____/____   ____/_____/____          Yes          Yes

                                                                                                No           No
 __                                               ____/_____/____      ____/_____/____          Yes          Yes

                                                                                                No           No
 __                                               ____/_____/____      ____/_____/____          Yes          Yes

                                                                                                No           No
 __                                               ____/_____/____      ____/_____/____          Yes          Yes

                                                                                                No           No
 __                                               ____/_____/____      ____/_____/____          Yes          Yes

                                                                                                No           No
 __                                               ____/_____/____      ____/_____/____          Yes          Yes
I have reviewed the AEs on this log and have assessed them for seriousness, causality, severity and outcome and confirm that, to the best of my knowledge, it
accurately reflects the study information obtained for this participant
PI signature_______________________________ Date:_________________________                                        Please check box if this is the last page used


 Completed by:
                 Name                                                    Signature                                                      Date


                 Name                                                    Signature                                                       Date
 SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                                                                                                   Page 27 of 30
       < Short Title/Acronym>                                               Sponsor
                                                                            No.
                                                                                         X X /            X X X X

       Subject                              Patient                             Site
       No.                                  Initials
                                                                                         Name

                                                                   CONCOMITANT MEDICATIONS LOG

                                                  Has the participant used any Concomitant Medications?     No            Yes, Complete below

CM No.                                                                                       Or tick if         Reason for use
                   Medication name                       Start date          Stop date      ongoing at     (Enter related AE diagnosis, or       Dose
             (Record <specify Generic or Brand>                                                                                                                 Route        Frequency
                                                       (DD/MMM/YYYY)                          end of         other reasons for use, e.g.         (Units)
                          name)                                            (DD/MMM/YYYY)
                                                                                             study?                  Prophylaxis)

  1.
                                                     ____/_____/_____ ____/_____/_____

  2.
                                                     ____/_____/_____ ____/_____/_____

  3.
                                                     ____/_____/_____ ____/_____/_____

  4.
                                                     ____/_____/_____ ____/_____/_____

  5.
                                                     ____/_____/_____ ____/_____/_____

  6.
                                                     ____/_____/_____ ____/_____/_____

  7.
                                                     ____/_____/_____ ____/_____/_____

                                                                                                                                             Please check box if this is the last page used



       Completed by:
                       Name                                                   Signature                                                           Date


                       Name                                                   Signature                                                            Date
       SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                                                                                                Page 28 of 30
       < Short Title/Acronym>                                         Sponsor
                                                                      No.
                                                                                  X X /        X X X X

       Subject                            Patient                        Site
       No.                                Initials
                                                                                  Name
                                          CONCOMITANT MEDICATIONS LOG (CONTINUATION PAGE)
                                                                                      Or tick if        Reason for use
                                                       Start date     Stop date      ongoing at    (Enter related AE diagnosis, or       Dose
CM No.             Medication name                                                                                                                      Route        Frequency
                  (Record Generic name)              (DD/MMM/YYYY)                     end of        other reasons for use, e.g.         (Units)
                                                                     (DD/MMM/YYYY)
                                                                                      study?                 Prophylaxis)


 __.
                                                 ____/_____/_____ ____/_____/_____


 __.
                                                 ____/_____/_____ ____/_____/_____


 __.
                                                 ____/_____/_____ ____/_____/_____


 __.
                                                 ____/_____/_____ ____/_____/_____


 __.
                                                 ____/_____/_____ ____/_____/_____


 __.
                                                 ____/_____/_____ ____/_____/_____


 __.
                                                 ____/_____/_____ ____/_____/_____


 __.
                                                 ____/_____/_____ ____/_____/_____

                                                                                                                                     Please check box if this is the last page used



       Completed by:
                       Name                                             Signature                                                         Date


                       Name                                             Signature                                                          Date
       SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                                                                                        Page 29 of 30
< Short Title/Acronym>                                          Sponsor
                                                                No.
                                                                          X X /         X X X X

 Subject                          Patient                          Site
 No.                              Initials
                                                                          Name

                   PRINICIPAL INVESTIGATOR’S SIGN OFF


Principal Investigator’s Signature Statement:


I have reviewed this CRF and confirm that, to the best of my knowledge, it accurately reflects the study
information obtained for this participant. All entries were made either by myself or by a person under my
supervision who has signed the Delegation and Signature Log.


Principal Investigator’s Signature:



__________________________________                         Date of         __ __/ __ __ __ / __ __ __ __
                                                          Signature:          (DD / MMM / YYYY)
Principal Investigator’s Name:


________________________________________


 ONCE SIGNED, NO FURTHER CHANGES CAN BE MADE TO THIS CRF
           WITHOUT A SIGNED DATA QUERY FORM.




SHORT STUDY TITLE, Study CRF Version X Date XX/XXX/XXXX                                        Page 30 of 30

								
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