Sample Case Report Form

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A Case Report Form (CRF) is used in clinical trials to track and report demographic and medical information concerning study participants. This Sample Case Report Form may be used as a template when creating a Case Report Form for a new study. This CRF includes information about the inclusion criteria, the exclusion criteria, demographics, initial screening, second visit, and final visit details. This CRF can be used by individuals or entities that want to undertake a new study and want to track vital information of study participants.

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									A Case Report Form (CRF) is used in clinical trials to track and report demographic and
medical information concerning study participants. This Sample Case Report Form may
be used as a template when creating a Case Report Form for a new study. This CRF
includes information about the inclusion criteria, the exclusion criteria, demographics,
initial screening, second visit, and final visit details. This CRF can be used by
individuals or entities that want to undertake a new study and want to track vital
information of study participants.
                                                   Case Report Form

                         Study Title: __________________________________
                      Date Informed Consent Form Signed ____________________


Inclusion Criteria                                                                          Yes    No*

 1.


 2.


 3.


 4.


 5.


*If any inclusion criteria are checked “no,” the patient is not eligible for the study.


Exclusion Criteria                                                                          Yes*   No

1.


2.


3.


4.


5.

* If any exclusion criteria are checked “yes,” the patient is not eligible for the study.



                                                       Demographics
Race: (check one)
____ American Indian or Alaskan Native
____ Asian
____ African American
____ Native Hawaiian or other Pacific Islander Ethnicity:
____ Caucasian


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Ethnicity: (check one)                               Gender: (check one)

____ Hispanic or Latino                              _____ Male
____ Non-Hispanic or Latino                          _____ Female


Date of Birth:_______________________ (mm/dd/yyyy)



                                       Initial Screening
Vital Signs
Please enter all vital sign information using leading zeros as applicable.

Pulse rate: ___________ Bpm
Blood pressure: ___________/_____________ mmHg


Height: ______ ft. ______ in.
Weight: _____________ lbs.


Medical History

Medications currently taking; (Include all prescription, non-prescriptions, and
vitamins/supplements):
___________________________________________________________________________
___________________________________________________________________________


Is there any relevant medical history in the following systems?
Code    System                  *Yes   No           Code    System                    *Yes   No

1       Cardiovascular                              9       Neoplasia

2       Respiratory                                 10      Neurological

3       Hepato-biliary                              11      Psychological

4       Gastro-intestinal                           12      Immunological

5       Genito-urinary                              13      Dermatological

6       Endocrine                                   14      Allergies

7       Haematological                              15      Eyes, ear, nose, throat

8       Musculo-skeletal                            00      Other


© Copyright 2011 Docstoc Inc.                                                                     3
*If YES for any of the above, enter the code for each, give details (including dates), and state if
the condition is currently or potentially active. If giving details of surgery, please specify the
underlying cause. Use a separate line for each condition.
                                                                                     Currently Active?

 Code                                    Details (including dates)                          Yes   No




Laboratory Analysis                                                                          Initials
                                                                                 Taken by
Blood for haematology and biochemistry


              Repeat Sample Required?                    Date Taken (dd mmm yyyy)
         Haematology

         Clinical Chemistry



Physical Examination

System                                                               *Abnormal      Normal
General Appearance

Heart

Lungs

Abdomen

Extremities


Add Notes/Study Specific Information:




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                                         Second Visit
Vital Signs
Please enter all vital sign information using leading zeros as applicable.

Pulse rate: ___________ Bpm
Blood pressure: ___________/_____________ mmHg


Laboratory Analysis                                                                     Initials
                                                                             Taken by
Blood for haematology and biochemistry


              Repeat Sample Required?              Date Taken (dd mmm yyyy)
         Haematology

         Clinical Chemistry



Physical Examination

System                                                         *Abnormal        Normal
General Appearance

Heart

Lungs

Abdomen

Extremities


Add Notes/Study-Specific Information:




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                                          Final Visit
Vital Signs
Please enter all vital sign information using leading zeros as applicable.

Pulse rate: ___________ Bpm
Blood pressure: ___________/_____________ mmHg


Laboratory Analysis                                                                     Initials
                                                                             Taken by
Blood for haematology and biochemistry


              Repeat Sample Required?              Date Taken (dd mmm yyyy)
         Haematology

         Clinical Chemistry



Physical Examination

System                                                         *Abnormal        Normal
General Appearance

Heart

Lungs

Abdomen

Extremities


Add Notes/Study Specific Information




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                                             End of Study/Early Termination

Date Study Ended:      ___ ___ / ___ ___ / ___ ___ ___ ___
(MM/DD/YYYY)


Date Last Study Medication Taken:             ___ ___ / ___ ___ / ___ ___ ___ ___

(MM/DD/YYYY)



Reason for Termination
(Please mark only the primary reason. Reasons other than “Completed Study” require an explanation.)
      Completed study
      AE/SAE (complete AE CRF & SAE form, if applicable) _________________________________________________________________
      Lost to follow-up              _______________________________________________________________________________________________

      Non-compliant participant                _____________________________________________________________________________________

      Concomitant medication ______________________________________________________________________________________
      Medical contraindication ______________________________________________________________________________________
      Withdrew consent        _____________________________________________________________________________________________

      Death (complete SAE form) ______________________________________________________________________
      Other    __________________________________________________________________________________________________________




        © Copyright 2011 Docstoc Inc.                                                                                         7

								
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