SOP 13/V1 Effective Date: 05/09/2012

IRB, TMC

Management of Premature Termination/ Suspension/Discontinuation of the study Page 1 of 6

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

Title: Management of Premature Termination / Suspension /Discontinuation of the study

SOP Code: SOP 13/V1 Date : 05/09/2012 Pages: 1 to 6

SOP 13/V1 Effective Date: 05/09/2012

IRB, TMC

Management of Premature Termination/ Suspension/Discontinuation of the study Page 2 of 6

13.1 Purpose

The purpose of this SOP is to describe how the IRB proceeds and manages the premature termination/suspension/discontinuation of a research study. Research studies are usually terminated as per the recommendation of the IRB, DSMSC, PI, sponsor or other authorized bodies wherein subject enrollment and subject follow-up are discontinued before the scheduled completion of the study. 13.2 Scope

This SOP applies to any study approved by IRB that is being recommended for termination/suspension/discontinuation before its scheduled completion. 13.3 Responsibility

It is the responsibility of the Chairperson, IRB to terminate any study that the IRB has previously approved when the safety or benefit of the study participants is doubtful or at risk, also to review the termination suggested by DSMSC, PI, Sponsor or other authorized bodies. The secretariat is responsible for management of the premature termination/ suspension/discontinuation process. 13.4 Detailed instructions

13.4.1 Receive recommendation for study termination / suspension /

discontinuation The secretariat will receive recommendation and comments from DSMSC, PI,

Sponsor or other authorized bodies for premature termination of study. The IRB members/Chairperson can prematurely terminate the study if protocol

non-compliance/violation is detected and IRB decision is to terminate the study due to any reason.

For e.g.- Frequency of SAEs occurring at trial site may require the study to be prematurely terminated for the safety of the patients.

The secretariat will inform the PI to prepare and submit a protocol termination package along with Premature Termination Report (available at IRB office)

The secretariat will receive the study protocol termination prepared and submitted by the PI and verify the contents of the report for inclusion of:

o Premature Termination Report/suspension/discontinuation(AX1- V1/SOP13/V1) signed and dated by the PI and/or other material (letter from Principal Investigator/sponsor etc)

o The Secretariat will check the completeness of the information o The Secretariat will receive and acknowledge the reports.

SOP 13/V1 Effective Date: 05/09/2012

IRB, TMC

Management of Premature Termination/ Suspension/Discontinuation of the study Page 3 of 6

13.4.2 Review and discuss the Termination / suspension/discontinuation report

IRB will review the termination report suspension/discontinuation at regular full board meeting or expedited review meeting.

The Secretary in the meeting will inform of the premature termination suspension/discontinuation of the project and the IRB members will review the Premature Termination Report (AX1- V1/SOP13/V1) along with relevant SAE report/DSMSC reports

If the Premature Termination Report suspension/discontinuation is unclear/more information is required from the PI, the Secretariat is instructed to send a query to the PI.

13.4.3 Notify the PI

The Secretariat will prepare a notification letter acknowledging the acceptance of termination /suspension/discontinuation or query letter to request information regarding the premature termination /suspension/discontinuation.

The Secretariat will send the notification letter to the PI for their records within 14 days after the meeting.

If a query is sent to PI, on receipt of the reply letter, it is reviewed in the forthcoming full board meeting /expedited review meeting and steps in 13.4.2 will be performed by the secretariat.

13.4.4 Store the Report

The secretariat will keep the original version of the Premature Termination suspension/discontinuation report in the study file and send the file to archive.

The study documents will be stored for a period of 3 years from the date of project termination.

References

1. World Health Organization, Operational Guidelines for Ethics Committees that Review Biomedical Research, (Geneva 2000)- www.who.int/tdr/publications/publications/ (last accessed 24 March 2008).

2. International Conference on Harmonization, Guidance on Good Clinical Practice (ICH GCP) 1996 - http://www.ich.org/LOB/media/MEDIA482.pdf (last accessed 24 March 2008)

SOP 13/V1 Effective Date: 05/09/2012

IRB, TMC

Management of Premature Termination/ Suspension/Discontinuation of the study Page 4 of 6

AX1- V1/SOP13/V1

Premature Termination/Suspension/Discontinuation Report

TMH Project No.: Protocol Title: PI: E-Mail: Study Site: Sponsor: IRB Approval Date: Date of Last Progress Report Submitted to IRB

Study Start Date: Termination/ suspension/discontinuation Date:

Study Participants

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: (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: __________

SOP 13/V1 Effective Date: 05/09/2012

IRB, TMC

Management of Premature Termination/ Suspension/Discontinuation of the study Page 5 of 6

o Any Impaired participants

None_____

Physically _____

Cognitively _____

Both _____

SAE (Total No.):

SAE Event:

Summary of Results:

Reason for Termination/Suspension/Discontinuation:

PI Signature: Date:

SOP 13/V1 Effective Date: 05/09/2012

IRB, TMC

Management of Premature Termination/ Suspension/Discontinuation of the study Page 6 of 6

Flow Chart

Receive study termination/suspension/discontinuation

/report

Review and Discuss Termination / suspension / discontinuation report

Notify the Principal Investigator

Store the Documents