Signature Manifestation Page

Document Number: QMS-OCD-30301 (014972)

Document Title: Transition to the New Clinical Synopsis and Protocol
Development Process

Lifecycle State History:

Date : 30 Sep 2020 00:05:27 (GMT-04:00)
Lifecycle State : Effective

Date : 26 Aug 2020 09:19:09 (GMT-04:00)

Lifecycle State : Authorised

Electronic Signatures:
Signed By : Kathleen L. O'Donnell (odonnekl)
Decision : Approved
Decision Date : 25 Aug 2020 16:53:46 (GMT-04:00)
Role : Approver
Purpose : Approve QMS-OCD-30301 - Transition to the New Clinical Synopsis
Meaning Of Signature : I approve this document as Business Unit QA/Compliance.

Signed By : Richard Boucher (boucher2)

Decision : Approved
Decision Date : 26 Aug 2020 08:53:29 (GMT-04:00)
Role : Approver
Purpose : Approve QMS-OCD-30301 - Transition to the New Clinical Synopsis
Meaning Of Signature : I approve this document as Management.

Signed By : Michelle Hudson (hudsonm6)

Decision : Approved
Decision Date : 26 Aug 2020 09:19:00 (GMT-04:00)
Role : Approver
Purpose : Approve QMS-OCD-30301 - Transition to the New Clinical Synopsis
Meaning Of Signature : I approve this document as Management.

Page 1 of 1
 Transition to the New Clinical Synopsis and Protocol
Development Process

QMS-OCD-30301, v01 BMS Information Page 1 of 5

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 Transition to the Revised Clinical Protocol Development Process

1.0 PURPOSE
This document outlines the strategy to transition to the new Clinical Synopsis, Protocol and Protocol Amendment
development process defined in SOP - Clinical Protocol Development and SOP - Clinical Protocol Synopsis
Development.
2.0 SCOPE

This transition plan is applicable to all BMS sponsored Phase I through IV studies as of the effective date of the
SOP. This includes heritage BMS (hBMS) sponsored interventional studies as well as those hBMS studies managed
by a CRO.

This plan and the applicable procedural documents are not applicable to heritage Celgene studies.

3.0 TRANSITION PLAN

3.1 New Studies
The transition plan for a particular study will be dependent on the stage of protocol development (e.g., at synopsis
stage or protocol stage) at the time of effective date of the procedural documents. Guidance is provided in the
table below. For synopsis or protocol documents that are in development at the time of the effective date of the
procedural documents, the template may continue to be used as drafted. All protocols are required to be
submitted to the Protocol Review Committee (PRC) for approval.

Study Status Implementation Plan for Implementation Plan for Protocol

Synopsis

New studies where synopsis  No change, continue  Follow the new procedural
approval1 will occur by October existing synopsis document for protocol development
31, 2020 development

New studies where synopsis
approval will occur on November
1, 2020 or after
 Follow the new procedural  Follow the new procedural
document for synopsis document for protocol development
development
 Convert to new synopsis
model document template

New studies where PRC approval  Not applicable  No change, continue existing
of the protocol will occur by protocol development
October 31, 2020

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 Transition to the Revised Clinical Protocol Development Process

Study Status Implementation Plan for Implementation Plan for Protocol

Synopsis
New studies where PRC approval  Not applicable  Follow the new procedural
of the protocol will occur on documents for protocol
November 1, 2020 or after development
1
In R&ED, the synopsis is approved by the Therapeutic Area Head; in GDD, the synopsis is approved by the GDD
Protocol Review Committee.
3.2 Ongoing Studies
Depending on the status of the study, i.e., how close it is to study completion, or whether there is an amendment
currently in development at the time of the effective date, guidance is provided on the implementation plan in the
tables below.

Study Status Implementation Plan for Protocol Amendment

Ongoing studies expected to
have End of Study Last Patient
Last Visit (LPLV) by March 31,
2021
 Develop protocol amendment following new procedural document for
Clinical Protocol Development.
 No change to nomenclature of amendment documents. Country/Site
Specific Protocol Amendment stand-alone template may continue to
be used as applicable.

Ongoing studies expected to
have End of Study LPLV on April
1, 2021 or after
 Follow new procedural document for protocol development.
 Use Global or Local Protocol Amendment nomenclature starting at the
time of the next amendment.
 Country/Site-Specific Protocol Amendment stand-alone template is no
longer allowed.

Ongoing studies where PRC
approval of the protocol
amendment will occur by
October 31, 2020
 No change, continue existing protocol amendment document
development.
 No change to nomenclature of amendment documents. Country/Site
Specific Protocol Amendment stand-alone template may continue to
be used as applicable.

Ongoing studies where PRC
approval of the protocol
amendment will occur on
November 1, 2020 or after
 Follow new procedural document for protocol development.
 Use Global or Local Protocol Amendment nomenclature starting at the
time of the next amendment.
 Country/Site-Specific Protocol Amendment stand-alone template is no
longer allowed.

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 Transition to the Revised Clinical Protocol Development Process

4.0 TRANSITION PLAN - OUTSOURCED STUDIES

A risk-based assessment will be led by Global Alliance Management (GAM) and Global Vendor Oversight &
Operations (GVOO), in collaboration with Clinical Research Organization (CRO) and BMS Subject Matter Experts
(SMEs), to evaluate CRO alliance partner’s clinical protocol development processes. This assessment is to
determine the differences between the BMS requirements and definitions versus those used by the CROs.

Based on the assessment, as needed, GAM and GVOO will ensure appropriate updates to agreements (e.g.,
contract, Quality Agreement, etc.) with CROs are made to ensure the CROs are able to comply with the BMS
process expectations for developing clinical protocol documents that meet content and quality expectations. The
risk-based assessment of each CRO process will be ongoing. The timeline for the updates will be agreed with CRO
and BMS Subject Matter Experts. Once documentation is in place, the Transition Plan as indicated in the table
below will be started.

All CROs to which BMS outsources the responsibility for protocol development will be assessed by 31 December
2021.

BMS Clinical is responsible for the clinical protocol development process regardless of whether a study is
outsourced.

Study Status Implementation Plan

New/ongoing studies that are  Follow the new BMS process

outsourced to a CRO where  Use BMS templates for new initial protocols and protocol amendments
initial protocol or protocol
amendment is finalized after 6
months after the completion of
the risk-based assessment

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 Transition to the Revised Clinical Protocol Development Process

REFERENCES (including Forms and Templates)

Document ID# Title

QMS-SOP-30301 Clinical Protocol Development
QMS-SOP-30302 Clinical Protocol Synopsis Development

DOCUMENT HISTORY

Effective See Signature Version 01 Author: Jasmine Rizzo

Date: Manifestation Page Number:
Description of Change(s):
 First Issuance
Approvers: Michelle Hudson, Sr. Director, Head of Clinical Research Scientists
Kathleen O’Donnell, Head Global Clinical QMS Process Improvement, Global Quality Systems
Richard Boucher, Executive Director, Clinical Trial Business Partnerships

Reviewers: N/A

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