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                    Standard Operating Procedure
                       for Initiation of a CTIMP


SOP Number: JBRU/SPON/S20/02                                        Effective Date: 04/02/10


Version Number & Date of Authorisation:                             Review Date: 04/02/12
V02, 29/01/10


eDocument kept:
S:\CLINICAL_TRIALS\SOPs\EFFECTIVE_SOPs_Guides\SPONSOR SOPs\SPON_S20_SOP initiation of a CTIMP
V02.doc




                                    SOP for Initiation of a CTIMP
                                       JBRU/SPON/S20/02
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Revision Chronology:


                        Effective
SOP ID Number:                        Reason for Change:                          Author:
                        Date:
                                                                                  Ira
JBRU/07/INT/S06/00 20/12/2007         N/A
                                                                                  Jakupovic
                                      To separate the Trial and Site Initiation
                                      Procedure. To implement a new
                                                                                  Ira
JBRU/SPON/S20/01        15/10/2008    numbering system and formatting
                                                                                  Jakupovic
                                      changes to comply with SOP on SOPs
                                      (JBRU/SPON/S01/02)
                                      Slight change of name Standard
                                      Operating Procedure for Initiation of a
                                      CTIMP instead of “Standard Operating
                                      Procedure for site Initiation”
                                      added a SOP training log, and a “List
                                      of template & Logs associated with the      Ann
                                      SOP” table. Added an “Acronyms              Cochrane
JBRU/SPON/S20/02        29/01/2010    table”. Added on the front page a row “     and
                                      SOP eDocument kept: “, to facilitate        Gurjinder
                                      the location of the electronic version of   Kahlon
                                      the SOPs. Added in the header “file
                                      name and path” to facilitate the
                                      identification of the electronic
                                      document Changed the logo to UCL.




ACRONYMS:
JBRU   Joint Biomedical Research Unit                  http://www.ucl.ac.uk/joint-rd-unit
GCP         Good Clinical Practice
SOP         Standard Operating Procedure
ISF         Investigator Site File
PI          Principal Investigator
CI          Chief Investigator
CRF         Case Report Form
SI          Statutory Instrument




                               SOP for Initiation of a CTIMP
                                  JBRU/SPON/S20/02
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                  Standard Operating Procedure
                     for Initiation of a CTIMP

1. PURPOSE

This Standard Operating Procedure (SOP) describes the procedure for Initiation for all
CTIMPs sponsored by UCL that are either single or multi-site Investigator led trials
from the date of this SOP being effective. Please check that you are reading the latest
version of this SOP: http://www.ucl.ac.uk/joint-rd-unit

It is recommended that a trial is not initiated until the JBRU are satisfied that all
essential documents, agreements and approvals are all in place at the relevant site(s).

2. JOINT UCLH/UCL BIOMEDICAL RESEARCH UNIT (JBRU) POLICY

All JBRU SOPS are produced, reviewed and approved in accordance with the JBRU
SOP on SOPs.

3. BACKGROUND

The European Clinical Trials Directive (EUCTD) 2001/20/EC, the GCP Directive
2005/28/EC and The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI
2004/1031) as amended set out the requirements for implementation of Good Clinical
Practice (GCP) in the conduct of clinical trials of medicinal products in humans within
Europe and the UK. For convenience, this document will use the term „Regulations‟ to
cover the requirements of the UK SI legislation.

The JBRU, which represents the Sponsor for UCL, is responsible for putting in place
the necessary procedures to secure the quality of every aspect of a clinical trial
including clinical trial activities carried out by institutions and investigators participating
in trials sponsored by UCL.

It is GCP requirement under Schedule 1 Part 2 of the Regulations, that:

(Principle 8). The Investigator and sponsor shall consider all relevant guidance with
respect to commencing and conducting a clinical trial.
(Principle 10). Before the trial is initiated, foreseeable risks and inconveniences have
been weighed against the anticipated benefit for the individual trial subject and other
present and future patients. A trial should be initiated and continued only if the
anticipated benefits outweigh the risks.
(Principle 12). A trial shall be initiated only if an Ethics Committee and the Licensing
Authority (MHRA for UK) comes to the conclusion that the anticipated therapeutic and
public health benefits justify the risks and may be continued only if compliance with this
requirement is permanently monitored.




                                 SOP for Initiation of a CTIMP
                                    JBRU/SPON/S20/02
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The site initiation process is designed to ensure that;

   each site has all essential documents in place for the site to conduct the study in
    compliance with the approved protocol and sponsor SOPs
   the site is furnished with all the sponsor‟s procedures and SOPs for trial conduct
    (such as safety recording and reporting, amendments, Notification of any urgent
    safety measures/ violations or serious breaches and completion of the JBRU self-
    monitoring template as per the risk assessment for monitoring), has read and
    understood each SOP by signing and dating the back of the SOP copy held in their
    ISF (as a minimum the Recording, Management and Reporting of AEs;
    JBRU/INV/S05)
   the site team has had GCP training which is current and documented
   the delegation of tasks log is completed before any trial related activities are
    performed by those members and they are authorised to do so by the CI/PI
   the pharmacy are provided with notification to proceed with ordering IMP (if
    applicable) and that procedures for receipt, dispensing, and accountability are
    documented
   the contact details are up to date and correct and site/pharmacy know how to
    contact the sponsor for day to day enquiries.

This procedure (in conjunction with site completion of the CI/PI self-monitoring
template), will facilitate JBRU oversight of site participation, recruitment activity and
trial conduct to ensure that;

a) The rights and well-being of human subjects are protected
b) The reported trial data are accurate, complete and verifiable from source
   documents
c) The conduct of the trial is in compliance with the currently approved
   protocol/amendment(s), with GCP and with the applicable regulatory requirements.

The following definitions will be used throughout this SOP

Trial Site – The location(s) where trial-related activities are actually conducted as per
the REC and MHRA submissions.

Site Registration Form – The form sent to each site to collect the site contact details
e.g. the CI/PI, Trials Pharmacist, Research Nurse or Trial Co-ordinator (who may also
act as the „site monitor‟ for the JBRU self-monitoring form completion).

List of Centres and Essential documents received in a multi-site trial-completed
for a multi-site trial as each new site is approved by REC, MHRA and their local R&D
office.

Site Feasibility Questionnaire- Completed by each site during site set-up phase to
allow assessment of site and their facilities versus requirements for a given trial

Site Pharmacy Questionnaire –Completed by each (new) site pharmacy prior to
obtaining local approvals (normally issued by the JBRU QA Pharmacist or Trial
Monitor). However it not intended to be a trial specific document per se, rather it will
assess the services provided and hence ability to perform operational functions within
the trial. (e.g. do they have enough storage capacity, access to -20 Freezer etc.)?
Local Pharmacies, such as those under UCLH pharmacy services will be well known to
the sponsor but newer pharmacies in particular will be required to complete this at the
trial set-up phase. It is recommended this is completed every two years.


                               SOP for Initiation of a CTIMP
                                  JBRU/SPON/S20/02
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Sponsor Contact Details Sheet-contains telephone, email, fax and address of the
JBRU team such as the Trial Co-ordinator, Trial Monitor (and QA Pharmacist when
they are in post).

Site Monitor-person(s) delegated at site to complete the CI/PI self-monitoring form on
behalf of the CI/PI.

CI/PI Self-Monitoring Template-depending on whether the site is the lead site where
the CI is based (CI self-monitoring template) or a PI site taking part (PI site self-
monitoring template) the form should be completed and maintained by the „Site
monitor‟ and sent to the JBRU at the frequency determined by the CI/Sponsor as per
the monitoring risk assessment. An initial Master copy should be in place from each
site before they are open to recruitment in order to ensure the site have a complete
document set before the trial commences. Thereafter, each form returned to the JBRU
as per risk assessment frequency should be signed off by the site and sponsor during
the trial conduct phase until the end of the trial.

Master Self-Monitoring Template-the Master copy of the CI/PI self-monitoring
template that represents the local site file status prior to any patient enrolment activity.
Ideally this should be in place before a site is open to recruitment and signed off by the
CI/PI only. Thereafter the form is called „First Template‟, „second template‟ etc. during
trial conduct. The CI Master template will have the agreed Risk Assessment level
required for monitoring as agreed by the CI/Sponsor and the PI must return the form at
this frequency to the CI/Sponsor. The form should be maintained every 2 months on
site to ease the process of self-monitoring and allow regular review and oversight of
trial conduct.

Monitoring Risk Assessment-The section of the CI Self-monitoring template
completed by the CI to determine the level of monitoring necessary for the trial. As a
minimum this will be 6 monthly (see Appendix 3)

Site Initiation Letter/email – The letter/email sent to each site with an outline of site
specific requirements (i.e. filing the site file according to the ISF Index and completing
the self-monitoring template ready for the initiation) and a request for potential initiation
dates/availability of the CI/PI to be present. If this is the CI site then a site visit will be
required for both the site and pharmacy, if a PI site then a phone call to the PI/site
team/site monitor/pharmacist/other key staff.

Investigator Site File (ISF)- the File(s) held at each site taking part in the trial which
hold the essential trial document set necessary for local approval and trial conduct at
site.

Site Initiation Pack (SIP) – This pack is sent both electronically and a hard copy
placed in the ISF which contains the following logs tailored to each trial to allow
sponsor oversight of trial conduct;

       Site Registration Form
       Staff Signature and Delegation of Tasks Log,
       Subject Screening Log,
       Subject Enrolment, Withdrawal and Study Completion Log, -
       Subject Master Identification Code List,
       Log of Substantial and Non-Substantial Amendments,
       Log of protocol Deviations, Violations , potential serious breaches/serious
        breaches and urgent safety measures.
       Trial Monitoring Visit Log (to document initiation and monitornig visits)
       Individual Staff SOP and courses training log
                                 SOP for Initiation of a CTIMP
                                    JBRU/SPON/S20/02
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       Trial/Protocol Training Log
    

The SIP must be tailored for each trial specific details by the JBRU member before it is
sent to site (e.g. Trial title, Eudract Number, Sponsor ID number, Investigator and Site
name.

The JBRU is responsible for initiating all site(s) participating in the conduct of CTIMPs
sponsored by UCL prior to the trial commencing at that site. If this is not possible prior
to screening activity then this must be fully documented and arrangements made as
soon as possible.

Site initiation should not occur until all essential trial documentation and approvals
are in place for each site, including any agreements pertaining to the trial such as IMP
supply or central laboratory agreement.

It may be performed via a visit to site or by a teleconference call with the key site team
members. As many trial staff as possible who will be involved in a trial on a daily basis
will be encouraged to attend and this should be documented on the Trial Meeting Log
of Attendance sheet from the SIP.

The CI/PI must be present during the initiation visit/call.

A separate visit/call to the site pharmacy may also be necessary in order to discuss the
IMP Management plan and other IMP related documents. This should be done as
close to the site visit date as possible however this will depend on the site trial
pharmacist availability.

4. SCOPE OF THIS SOP

This SOP covers the procedure that the JBRU must follow to ensure that a site is
initiated prior to the screening and recruitment of any trial subjects following local NHS
R&D Permission. It describes the process for JBRU to follow to initiate a site either
immediately prior to or following R&D approval and outlines the procedure to ensure all
the necessary information for sponsor requirements and key regulatory requirements
during trial conduct.

This SOP does not cover the procedure that must be followed to set-up a new CTIMP.

5. RESPONSIBLE PERSONNEL

The JBRU Trial Coordinator (TC) is responsible for:

   ensuring the CI/PI has received a copy of the CI/PI self-monitoring template at the
    proposal stage of the trial and that they are aware of their requirement to keep it up
    to date as the trial is approved and documents are generated.
   liaising with the nominated JBRU Trial Monitor and Joint R&D Governance Co-
    ordinator for trials pending R&D approval where the CI is based at UCLH NHS
    Foundation Trust as the lead site of the trial in order to notify them of pending site
    initiation requirements.
   set-up of each trial site for those CTIMPs sponsored by UCL. Where R&D NHS
    permissions are performed via the NIHR CSP by the Research Governance Co-
    ordinators, a signature of the TC may also be necessary prior to the R&D approval
    letter being issued for those UCLH NHS Foundation Trust sites approved by the
    Joint R&D office.

                               SOP for Initiation of a CTIMP
                                  JBRU/SPON/S20/02
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     ensuring the trial essential document set is complete and all approved essential
      documents and contracts are in place and signed off by all respective parties.
     liaising with the JBRU Contracts Team and finalising 3 copies (one for pharmacy,
      site and JBRU) of the Clinical Trial Site Agreement (CTSA) and other agreements
      as necessary for the trial.
     requesting from the CI/PI the return of the CI/PI self-monitoring form and reviewing
      it with the JBRU Trial Monitor to ensure that the site is ready for initiation.
     booking a site visit and notifying the monitor of the initiation date (via email) once
      R&D approval is imminent.
     creating a section in the TMF for each site taking part in the trial and filing local
      approvals and documents as per section 6.3.
     checking that the list of sites provided to the JBRU Data Information Manager is still
      current and ensuring that the CI has completed and returned the List of Centres
      and Essential Documents received for a Multi-site trial, Appendix 2
      If some sites declared in the original IRAS application will no longer take part, the
      TC needs to notify the JBRU REDA data manager. Conversely if additional sites
      are submitted as substantial amendments, the TC needs to notify the Data
      Information Officer
     sending the initiation letter/email, along with the trial tailored Site Initiation Pack
      (SIP) to the CI/PI and nominated site contact for review. The pharmacist should
      also be contacted to arrange an initiation visit/call.
     creating an ISF and Pharmacy Site file. These will be provided for each site taking
      part prior to or at the time of site initiation.
     creating initiation slides to present to site staff for awareness of sponsor
      requirements, PI requirements as per UK Regulations and to summarise current
      approved documents for use in the trial. The slides are not intended to replicate PI
      training of the protocol to their team; this should be provided by the CI/PI at site and
      documented in the training log supplied in the site initiation pack.
     documenting the Site Initiation Procedure in the Sponsor TMF.


The JBRU Trial Monitor (TM)/QA Pharmacist (when in post) is responsible for:

         working with the TC to prepare and book the site initiation visit.
         attending the initiation visit/call with the TC and ensuring readiness for
          undertaking review of self-monitoring template returns from site during the trial
          conduct phase and/or of subsequent monitoring visits during trial conduct to
          audit the self-monitoring template(s) completion or conduct a site monitoring
          visit when required by JBRU (see JBRU/SPON/S19/02).

The JBRU Contract Manager(s) is responsible for:

         finalising the Clinical Trial Site Agreements (CTSAs) with the TC and any other
          Agreements as necessary per trial (such as IMP Supply Agreements or Central
          Laboratory Agreements). A final signed and dated CTSA (and any other
          agreements) must be returned to the JBRU prior to initiating any sites.


6. PROCEDURES FOR JBRU

6.1       Pre-initiation Procedure for all Sites

6.1.1      Ensure the essential document set is complete (including CI‟s JBRU
           CV, GCP certificate and protocol signature pages) and all TC
           agreements are signed off and finalised. Prepare or follow up on
                                  SOP for Initiation of a CTIMP
                                     JBRU/SPON/S20/02
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         any outstanding contracts/documents for the trial.
6.1.2    For the Lead site, R&D NHS permission may be pending or
         already in place at the time of the initiation, depending on what
         documents remain outstanding. The final document set should be
         ready and all Governance checks (if applicable) made on the trial
         or at the QA review stage if an NIHR CSP trial. (If any findings are
         made at the CSP QA stage by the R&D Co-ordinators, the trial
         initiation should be delayed until these are rectified and/or
         approved). If a PI site request a copy of the R&D approval letter for
         the JBRU file.
6.1.3    Request the „CI/PI Master Self-Monitoring Template’ is
         completed by site and reviewed by JBRU prior to issuing the
         initiation letter/email.
6.1.4    Review the sponsor TMF as per the current TMF checklist
         against the Master CI/PI Self-monitoring form. Highlight any
         missing documents from either file and arrange for them to be
         sent/retrieved from site during initiation.

6.1.5  Issue the Initiation Letter/email along with the tailored SIP to the JBRU
       site. For UCLH sites request the site make available their trial files TC/TM
       and any central files (for trial personnel training, CVs etc) for
       review and request access to a laptop/projector and location of a
       suitable meeting room to accommodate all attendees, including the
       CI. If a PI site arrange a call with PI/team and pharmacist.
6.1.6  Ask for the names of site attendees. The CI/PI must be present
       for the initiation visit/call.
6.1.7  Contact lead Pharmacist in order to arrange a pharmacy Initiation.
       N.B. some pharmacies may require a notice period for booking an
       initiation visit. Suggest suitable dates/times for the initiation visit to
       take place.
6.1.8  Inform TM of intended initiation visit date(s).
6.1.9  Prepare ISFs and pharmacy file templates as per Appendix 1.
       Email these documents to site and pharmacy providing instructions
       for filing of documents and ordering of site file. If unable to email,
       courier/take the prepared files to site at time of initiation. Request
       confirmation of receipt.
6.1.10 Prepare trial initiation slides (as per the template available on S
       drive) and tailor them to the trial. Send to the investigator team by
       email ahead of initiation if possible for the projection/laptop set-up
       at site. Alternatively take a data stick and several printed copies,
       and ensure a copy is filed in the site file.
6.1.11 Ensure a thorough understanding of the approved protocol,
       essential document set and trial procedures before conducting the
       initiation




6.2     Site Initiation Procedure for UCLH Site(s)/Pharmacy

6.2.1    Site initiation should take place prior to the pharmacy initiation JBRU
         unless due to trial logistics where this may not be possible.      TC/TM
6.2.2    Send a courtesy email to site/pharmacy/JBRU monitor the day
         before initiation to remind them of the meeting date/time/venue.
6.2.3    Take along any copies of documents for the site file that are JBRU

                               SOP for Initiation of a CTIMP
                                  JBRU/SPON/S20/02
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         missing i.e. final CTSA or other agreement that requires the site to TC/TM
         hold a wet ink copy, the sponsor TMF checklist, the completed
         CI/PI self-monitoring form (for signature).
6.2.4    Present the initiation slides and discuss the sponsor SOP
         requirements with the team. Discuss trial conduct and ensure
         understanding of processes within the team. Request that
         delegated members sign each SOP back page to certify they have
         read and understood it. Copies may be requested by the sponsor
         to verify this during trial conduct.
6.2.5    Verify all required essential documents (including CVs and GCP
         certificates) are on file, and ensure ISF in line with index provided
         by sponsor.
         Ensure that all site contact details (as per the Site Registration
         form) are present and correct. Request that any changes to key
         personnel contact details are notified to the JBRU during trial
         conduct.
         File any missing documents as per the Master CI self-monitoring
         template review or ensure the site receive a copy as soon as
         possible.
         If the site have documents that the sponsor does not hold then
         copies should be made on site for the sponsor‟s TMF
6.2.6    Ensure the delegation log is completed by all team members and
         signed off by the CI/PI. If any team member(s) are not present
         during initiation, the log should be left for the team to complete and
         return to JBRU as soon as possible, including the trial pharmacy
         signature and sign off.
         If a PI site then instruct team to send to the unit asap once
         completed following the teleconference call.
         Ensure team are aware of the need to keep this log updated
         throughout the trial and send it to the JBRU with each completed
         self-monitoring template report.
6.2.7    Meet lead pharmacist and go through the Pharmacy file and
         ensure they are satisfied with the IMP management plan and
         other pharmacy related documents. Review the IMP storage
         arrangements.
6.2.8    File any missing documents or ensure the pharmacy receive a
         copy as soon as possible. If the pharmacy has documents that the
         sponsor does not then copies should be made for the sponsor‟s
         TMF.

6.2.9    Following R&D approval (or issue of open to recruitment letter) for JBRU
         the site, notify the pharmacy to request IMP shipment and send TC/TM
         the trial IMP order form (if applicable)

.6.3    Site Initiation Procedure for Non UCLH Sites

6.3.1    Undertake pre-initiation activities as per section 6.1            JBRU
6.3.2    Prepare (three copies) of the CTSA and send to the site for TC/TM
         signature (along with copies of any other relevant agreements
         required to be in place locally (if applicable))
6.3.3    Upon receipt of all local approvals (including R&D NHS
         permission), and signed CTSA, contact the site to arrange the
         teleconference with the site team for initiation.
6.3.4    Ensure the date/time/telephone number to dial in is made known to
         those wishing to take part. The PI must be involved in the
         Teleconference. Two calls maybe necessary-one for the PI and
                               SOP for Initiation of a CTIMP
                                  JBRU/SPON/S20/02
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         one for local Pharmacist.
6.3.5    Follow process as for sections 6.2.4-6.2.9                     JBRU
         Ensure site return:                                            TC/TM
         -Copy of the signed off delegation log,
         -Trial meeting log of attendance for those present to document
         who was present at the call
         -Receipt/acknowledgement of the ISF(s) and pharmacy files
         Any other outstanding documents as requested.
         File these in the JBRU trial file.

6.4     Post Initiation procedure

6.4.1    Document any findings, queries, missing documents and actions JBRU
         for site and pharmacy and summarise on the site initiation TC/TM
         summary letter and send to site and pharmacy.
6.4.2    Ensure follow up actions are completed (if applicable) before
         issuing “Open to recruitment” letter. This should not delay trial
         commencement if Pharmacy and site are ready and all other
         documents are in place.
6.4.3    Once all outstanding actions are completed (if applicable) issue the
         site (copy pharmacy) with the “open to recruitment” letter. The
         site is now ready to commence screening activities.
6.4.5    Notify the JBRU Data Information Officer (DIO) that the trial is now
         active and to be amended on Reda from the in set-up to active
         status.
6.4.6    File all site initiation documents in section 19 of the sponsor TMF
         including a copy of the current site delegation log.


7. REFERENCES

1. The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031) as
amended
2. EU Clinical Trials Directive 2001/20/EC
3. GCP Directive 2005/28/EC


8. APPENDICES

Appendix 1 ISF and Pharmacy File contents
Appendix 2 List of Centres and Essential Documents received for a Multi-site trial
Appendix 3 Risk based Monitoring Strategy as per the CI Self-Monitoring Template




                               SOP for Initiation of a CTIMP
                                  JBRU/SPON/S20/02
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Appendix 1 ISF and Pharmacy File Requirements

ISF Preparation:

      2 x A4 Lever Arch files (numbered with section dividers)
      Trial Specific A4 lever arch file labels (according to the template on the S: drive)
      Trial Specific ISF Index page(s)
      JBRU contact details sheet and (file at the front of the file)

Add the following to the prepared ISF:

      All current effective Investigator SOPs and associated forms
      SIP logs and templates (as per section 6.1 above)
      A copy of the current SAE report form and coversheet
      A copy of the current Pregnancy report form and coversheet
      A copy of the initiation letter/email request and Initiation slides filed

Pharmacy File Preparation:

      1 x A4 Lever Arch file (numbered with section dividers)
      Trial Specific A4 lever arch file labels (according to the template on the S: drive)
      Trial Specific Pharmacy Index page(s)
      JBRU contact details sheet and (file at the front of the file)

Add the following to the prepared Pharmacy File:

      All current JBRU Pharmacy Templates (available on S drive) each tailored per
       trial (or per IMP as applicable)-File note if pharmacy using own templates.
       Ensure contains equivalent information required.
      All Regulatory Documents (REC, MHRA, Local R&D) and amendment
       approvals (if applicable)
      Latest approved Protocol and signature page
      Trial Summary sheet (if applicable)
      IMP Management Plan (containing instructions per IMP/NIMP)
      Copy of pharmacy prescription and IMP label(s)
      The latest IB/IMPD/SmPC (maintained by site/pharmacy for SmPC updates)
      Agreements applicable to the site and IMP supply
      Copy of the signed CTA (Annex 1) submitted to the MHRA
      Signed File notes where any JBRU templates are not applicable (locally)




                                SOP for Initiation of a CTIMP
                                   JBRU/SPON/S20/02
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Appendix 2
                        LIST OF CENTRES & ESSENTIAL DOCUMENTS RECEIVED FOR A MULTI-SITE TRIAL


TRIAL TITLE:
Chief
                                                        Sponsor ID Number:
Investigator:
                                                          Copy of         MHRA
                                                                         approval                     Copy of
                                  Main Site Contact     Investigator                                               Other local
                                                                        date (if site   Signed       local R&D                         Delegation of
 Hospital Site and PI Name           email and           signed CV                                                agreements (if
                                                                         joined after    CTSA           NHS                             Tasks Log
                                     telephone            and GCP                                                   applicable)
                                                                          initial CTA                permission
                                                         certificate      approval)




                                                  Standard Operating Procedure for Initiation of a CTIMP
                                                                  JBRU/SPON/S20/02
                                                                     Page 12 of 15
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Appendix 3: Risk Based Monitoring Strategy as per the CI Self-Monitoring Template

Risk-based monitoring strategy level                         MINIMUM monitoring requirements

The CI together with the JBRU will determine                 This monitoring report needs to be
the risk level of the project, A, B, C or D as               maintained every second month on
defined below:                                               site by the trial team but only sent
                                                             to JBRU at the frequency
                                                             determined below:
A Low Risk                                                   Once a year : a year after the date
(e.g. a non-CTIMP non-invasive                               on the first signed consent form or
pathophysiology/imaging )                                    the finalised baseline template
B Medium (Similar to usual care)                             Once a year: a year after the date
(e.g. Therapeutic confirmatory use trial                     on the first consent form or the
(Phase III) or using a food supplement (eg.                  finalised baseline template
vitamins).
Is the subject receiving the same treatment
on trial as he would be off trial? If yes, this is
level risk B
C High                                                       Twice a year: (six months after the
                                                             date on the first consent form and a
(e.g. Therapeutic exploratory trial (Phase II)               year after the date on the first
                                                             signed consent form) or the
                                                             finalised baseline template
D Very High (Phase I)                                        To be defined by the phase I/II site
(e.g. gene therapy/cell therapy/first in man)                monitor (and/or) project manager.
                                                             The sponsor must be sent site
                                                             monitoring reports when available.
                                                             This form may also be used in
                                                             addition, and returned at the same
                                                             frequency as monitoring reports to
                                                             the Sponsor.
Please complete this section:
       This trial falls into category : X and this monitoring template will be sent to the
        Joint UCL/UCLH R&D Office Y times a year

       CI to justify why this trial falls into that category risk:

       Overall recruitment total expected (as approved by the REC and MHRA): X

       Overall Number recruited to date: X

       Number of patients at each site: X/Y (if applicable)

       Name of the person from the trial team completing this monitoring
        report and acting as a site monitor (This should not be the
        Investigator unless the Investigator leads the project on his/her
        own):




                                     SOP for Initiation of a CTIMP
                                        JBRU/SPON/S20/02
                                           Page 13 of 15
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9. TEMPLATES/LOGS ASSOCIATED TO THIS SOP:

   1     Appendix 1  Current JBRU SIP, IMP Management plan, Initiation slides, Site File
                     and Pharmacy document templates and Initiation letter
   2     Appendix 2 List of Centres and Essential Documents received for a Multi-site trial

   3     Appendix 3 Risk based Monitoring Strategy as per the CI Self-Monitoring
         Template


10. SOP DISSEMINATION & TRAINING

SOPs relevant to the JBRU only, will be distributed to the concerned JBRU staff, by the
named author under section 11.0 of the SOP. Staff involved by the SOP will sign the
SOP training log (Section 12. SOP TRAINING LOG) which is part of each SOP. In
addition each staff has an “Individual staff SOP training log” and will need to update it
once trained on the SOP.

In some instances, the SOP will be basic and the training will constitute of the person
reading the SOP and asking specific questions to the author of the SOP. In some
instances the staff member given training will carry out the procedure under supervision
of the author of the SOP or under supervision of a staff member who has been trained.
Both trainee and trainer will need to sign and date the “SOP training log” in section 12 of
each SOP held by the QA Manager and the “Individual staff SOP training log”.

11. SIGNATURE PAGE

 Author and Job Title:           Ann Cochrane and Gurjinder Kahlon, JBRU Trial Monitors
 Signature:

 Date:


 Authorised by:
                                 Helen Cadiou, QA Manager
 Name and Job Title

 Signature:

 Date:




                                     SOP for Initiation of a CTIMP
                                        JBRU/SPON/S20/02
                                           Page 14 of 15
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  12. SOP TRAINING LOG:
         Name of Staff               Job Title:                                     I confirm that I
         (Capital letters):                                                         understand & agree
                                     Department:
                                                                   Training         to work to this SOP   Name of Trainer
                                                                   Date             SIGNATURE             (if applicable)   Signature   Date
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                                                                         SOP for Initiation of a CTIMP
                                                                            JBRU/SPON/S20/02
                                                                               Page 15 of 15

				
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