institutional review board, tata memorial centre (irb, tmc) of amendedprotocol... · institutional...

SOP 06/V1 Effective Date: 01/01/2013

HEC, TMC

of 7 Review of Amended protocol/ Protocol related documents

Institutional Review Board, Tata Memorial Centre (IRB, TMC)

Title: Review of Amended protocol/ Protocol related documents

SOP Code: SOP 06/V1 Date: 05/09/2012 Pages: 1 to 7


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6.1 Purpose

The purpose of this procedure is to describe how protocol amendments or any other amendments/letters are reviewed by the IRB 6.2 Scope

This SOP applies to amended study protocols/ documents and letters that are submitted for IRB approval. Amendments made to protocols or any other amendments related to the study may not be implemented until reviewed and approved by the IRB 6.3 Responsibility

It is the responsibility of the IRB secretariat to manage protocol amendments/ documents and letters. Receipt of the Amendment Package The amendment /documents forwarded by the PI is received by the secretariat. The

amendment /documents along with the covering letter should be accompanied by Amendment Reporting Form (AX2-SOP06/V1)

The secretariat will confirm that the: changes or modifications in the amended version are underlined or highlighted along with detailed summary of changes

The Secretariat will check for completeness of the submission and inform the Principal Investigator telephonically to submit the required documents at the earliest, if any of the documents are missing/ incomplete.

The secretariat of the IRB should follow the procedures as in SOP03/V1(Procedures for Management of protocol submission)

The Member Secretary, IRB, classifies the amendments into minor or major and tables the major amendments on the agenda of the subsequent scheduled meeting (for Minor amendments refer to 6.4.3). The amendments and other documents which need full board review are processed as per the SOP 04a/V1 6.4. Review amended protocols/documents/letters: Review as per Section 4.3

SOP 04a/V1

6.4.1 Decision

If the IRB approves the amendments, the decision is communicated to the PI If the IRB does not approve the amendments, the secretary should immediately

notify the investigator in writing of the decision and the reason for not approving the amendment

If the IRB recommends or suggests modifications to any of the documents, or the amendments, the secretariat sends a written communication to the


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investigator about the specific changes asking him or her to make the necessary changes and resubmit the documents to IRB

6.4.2 Storage of Documents:

File the amendments in the corresponding research protocol file, as per the SOP 10/01 on documentation and archival. 6.4.3 Minor amendments and notifications:

Minor amendments (those that do not increase the risk or decrease the potential benefit to subjects) may be approved by the in the expedited review subcommittee meeting (Refer SOP no. 04b/V1.) Minor notifications may be noted by the Member Secretary, IRB and not tabled in IRB meeting This may include but may not restrict to:

Renewed insurance policy DCGI and DGFT approvals Administrative notes Documents of administrative nature

References

1. World Health Organization, Operational Guidelines for Ethics Committees that Review Biomedical Research (Geneva 2000) Retrieved from-www.who.int/tdr/publications/publications/ accessed 14th September 2008

2. International Conference on Harmonization, Guidance on Good Clinical Practice (ICH GCP) 1996 Retrieved from-http://www.ich.org/LOB/media/MEDIA482.pdf accessed 14th September 2008

3. Code of Federal Regulation (CFR), 21 §56.110, The United States of America, 1998

Glossary Amendment: Any change in protocol and documents from that of previously IRB approved protocol/document.


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AX1-V1/SOP06/V1

Amendment/Document Amendment Approval letter

Format for Approval for documents

Date Dr. , Principal Investigator, TMH Ref: Project No. Title Dear Dr. The following documents for the above referenced project were tabled and discussed during the IRB meeting held on (date) (time) (place) The following members of the IRB were present: Status: Approved / Approved with modifications/Resubmit This decision was taken by consensus. Neither Principal Investigator nor any of the study team members participated during the decision making of the IRB. Thanking you, Yours truly, Member-Secretary, IRB


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AX2-V1/SOP06/V1 IRB Secretariat

Amendment Reporting Form Project No. : Title : Principal Investigator : No. of amendment: Have the changes modifications in the amended versions been highlighted/ underlined? Yes No Does this amendment entail any changes in Informed Consent Form (ICF)

Yes No

If yes, whether amended ICFs are submitted pl. specify ICF Version No. & Date and its IRB approval

Please mention version no. and date of amended Protocol / Investigators Brochure / ICF Addendum.

o Target accrual of trial (entire study)

______________

o Total patients to be recruited at TMH (IRB

ceiling)__________

o Screened: __________

o Screen failures: __________

o Enrolled: __________

o Consent Withdrawn: _______Reason:

(Attach in format below)

o Withdrawn by PI: _________Reason:


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(Attach in format below)

o Active on treatment: __________

o Completed treatment : __________

o Patients on Follow-up: __________

o Patients lost to follow up: __________

o Any other: __________

o Any Impaired participants

o None_____

o Physically _____

o Cognitively _____

o Both _____

Signature of the Principal Investigator & Date:


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Receive the amendment package

Flow Chart

Determine whether Expedited or Full review.

Review amended protocols / documents / letters

Communicate decision to PI

Storage of documents