Blinding and Re-labeling of Clinical Trial Samples for Clinical Trial purpose

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1. 0 Objective

To lay down procedure for blinding and re-labeling of Clinical Trial samples for blinded Clinical Studies of the drug products.

2.0 Scope

This standard operating procedure is applicable for pharmaceutical formulation plant. The procedure is applicable for blinding and re-labeling of clinical trial samples procured or manufactured by pharmaceutical plant.

3.0 Responsibility

3.1 QA shall prepare the protocol for carrying blinding activity in-conjunction with clinical Research Department.

3.2 Plant Head shall facilitate the blinding activity of the CTS.

33. Clinical Research Department shall prepare randomization codes, review and support in preparation of the protocol for blinding activity.

3.4 DP shall execute the blinding and re-labeling of CTS as per the protocol.

3.5 Head, QA shall be responsible for compliance of this SOP.

4.0 Abbreviations and Definitions

DP                                        :  Designated Person

Blinding                        :  A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding refers to the subject(s) being unaware and double-blinding usually refers to the subject(s), investigator(s), monitor and in some cases, data analyst(s) being unaware of the treatment assignment(s).

Randomization      :  The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

IPs                              :  Investigational Products

CRO                          :  Contract Research Organization; CRO shall carry clinical trials for pharmaceutical plant.

PSF                           :  Product Specification File; File containing all product specifications, manufacturing and analytical docs related to CTS samples including copy of filled batch records of the IP(s) and comparator(s)

IOM                              :  Inter Office Memo

CTS                              :  Clinical Trial Supply/ Sample

CRD                             :  Clinical Research Department

SOPs                           :  Standard Operating Procedures

GCP                             :  Good Clinical Practice

CWH                           :  Central Warehouse

5.0 Procedure

5.1 QA in conjunction with Clinical Research Department shall prepare a protocol on carrying out blinding activity under following heads, but not limited to:

5.1.1 Objective

5.1.2 Scope

5.1.3 Responsibility

5.1.4 Abbreviations & Definitions

5.1.5 Pre-requisites

5.1.6 Procedure on blinding of CTS

5.1.7 Documentation plan

5.2 QA shall evaluate the packaging requirements and blinded labels requirements along with Packaging Development and Clinical Research Department.

5.2.1 Coded/ blinded labels text and other GCP requirements shall be evaluated by Regulatory Affairs, Clinical Research, R&D and QA departments

5.2.2 R&D shall support in generating the relevant specifications, test methods & packaging procedures for packing of Clinical Trial Samples.

5.3 CRD shall intimate QA and/ or Plant Head to plan for blinding activity to be carried out on CTS.

5.4 Upon receipt of request from the Clinical Research Department QA shall intimate DP for clinical trial samples blinding and re-labeling.

5.5 DP shall verify the PSF of the Clinical Trial Samples and certify the same indicating their suitability for carrying clinical trial on these samples.

5.5.1 PSF shall be prepared by QA in conjunction with R&D, if required.

5.5.2 PSF shall be given to DP by Head-QA for the verification of its contents by DP before initiating blinding activity on CT samples.

5.6 DP will send the requisition/IOM to QA for issuance of necessary pre-requisites.

5.7 The activity of blinding shall be undertaken by authorized and trained persons. Head-QA along with Plant Head shall constitute a team who shall support DP in blinding and re-labeling activity.

5.7.1 Head-QA shall plan for training of the team participating in the blinding activities.

5.7.2 If required, Head-QA to ensure the training of DP on certain SOPs applicable for carrying/executing the blinding activity.

5.7.3 The entry to the activity area shall be restricted. The entry and exit from the activity area shall be under discretion of DP.

5.7.4 The necessary arrangements for carrying out the blinding activity shall be thoroughly explored towards resulting the correct and error-free blinding of all CTS.

5.7.5 The temperature records wherever required shall be maintained.

5.8 The CTS samples shall be reconciled by QA & DP and the reconciliation shall be recorded accordingly.

5.9 All the filled records shall be handed over by DP to QA after the successful completion of the blinding activity. QA shall maintain all the records related to Clinical Trial Supply.

5.10 Signed and sealed copy of randomization and coding pattern for relabeling of CTS shall be obtained from Clinical Research department by Head-QA.

5.10.1 Head-QA shall forward the sealed copy to DP for blinding as per the treatment assignment(s)/ groups, based on the information given by CRD.

5.10.2 De-coding in event of adverse event and/ or adverse drug reaction shall be done as per the suitable procedures laid down by CRD.

5.10.3 Randomization list will be patient specific and treatment specific. Patient IDs shall be allotted to different treatment groups depending on the design of the study by CRD.

5.11 The CTS shall be properly packed under supervision of DP and DP shall handover CTS to plant QA for dispatch to the trial site(s)/ CRO/ CWH along with the following necessary documents:

5.11.1 Letter with necessary labeling including the handling/storage instructions duly signed by Head-QA

5.11.2 Drug acknowledgement receipt. This receipt shall be asked for sending back by the Investigator/CRO/CWH to the Head-QA.

5.11.3 The information regarding the dispatch of the CTS shall be duly filled in the CTS accountability log by Head-QA.

5.12 All the documents and records shall be reconciled and verified before dispatching the CTS to the trial site(s)/ CRO/ CWH/ by Head-QA.

5.13 If required, shipping verification for ensuring safe delivery of the CTS samples at trial site(s) shall be planned by QA.

5.14 In case of Clinical Trial Supply to Regulatory markets, Qualified Person shall release the clinical trial samples for dispatch to CRO based on the understanding from facility audit, analytical results of the supply samples, report of handling of clinical trial supply and compliance statement of Designated Person.

6.0 Forms and Records

Nil

7.0 Distributions

7.1 Master Copy –              Documentation Cell (QA)

7.2 Controlled Copies –      Quality Assurance, Production, Quality Control, Stores, Materials, Management, Clinical Research, Research and Development and Regulatory Affairs

8.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

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