SOP Title Study Document Handling, Storage and Archival

SOP Number 1
SOP Version Version 1.0 dated 17th April, 2020
Effective Date 19th April, 2020
Distribution 1. All study staff at trial sites
2. ICMR Study Team

Document History
SOP Version Effective Date Edits Reasons for edits
1.0 19.04.2020

Prepared by Dr. Pranab Chatterjee

Reviewed by Dr. Anup Agarwal
Approved by Dr. Aparna Mukherjee
 Table of Contents

Sr. No. Title Page No.

Purpose
1 3

2 Scope 3
Responsibility
3 3

4 Definition 3
Abbreviation
5 3

6 Applicable Regulation and Guidelines 4

Procedures
7 4

8 References 5
Annexure/Attachments
9 5
 Study Document Handling, Storage and Archival
1. PURPOSE
This SOP describes general instructions for storage, security, access and retention of study related documents so that the
study records are available for review/inspection at any time for monitoring, audit and if required by any
regulatory body and confidentiality of information is maintained.

2. SCOPE
The procedures defined in this SOP are applicable for PLACID Trial at trial sites.

3. RESPONSIBILITIES
3.1 Study staff, under the leadership of the Principal Investigators, will be responsible for following procedures
described in this SOP.

3.2 The PI and Co-I are responsible for implementation of this SOP

4. DEFINITIONS
Clinical research records: The records that describe or record the methods, conduct, and/or results of a clinical
trial, and the actions taken. The records may be in any form, including written and electronic records; and scans,
x-rays, and electrocardiograms.

Clinical research records include:

Case history: A detailed account of relevant information gathered about a subject. This information includes
the case report forms and supporting data including, for example, signed and dated consent forms and medical
records, including, for example, progress notes of the physician, the individual’s hospital chart(s), and the
nurses’ notes as required by regulatory authority.

Essential documents: Documents that individually and collectively permit evaluation of the conduct of a study
and the quality of the data produced.

Source documents: The original documents, data, and records containing clinical findings, observations, or
other activities in a clinical research study that allows the reconstruction and evaluation of the study. Examples
of source documents include: hospital records, clinical and office charts, laboratory notes, memoranda, subjects’
diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments,
copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic
negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the
laboratories, and at medico-technical departments involved in the clinical trial.

IRB/EC records: The documentation maintained by the institution, or when appropriate, by IRB/EC, of
IRB/EC activities, as required by institutional policy and regulatory authority.

5. ABBREVIATIONS
Co-I Co-Investigator
EC Ethics Committee
GCP Good Clinical Practices
ICH International Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use
 IRB Institutional Review Board
NICED National Institute of Cholera and Enteric Disease
PI Principal Investigator
SOP Standard Operating Procedures

6. APPLICABLE REGULATIONS AND GUIDELINES

Amended Schedule Y, Drugs and Cosmetic act, 2005
ICH guidelines for Good Clinical Practice E6 (R1)

7. PROCEDURES

General Instructions
● Documents should be stored in facilities which can be locked or physically guarded at all times
● Lockers and cabinets are fit with locks, and when used for storage of study related materials are locked at
all times
● Full set of all keys is accounted for
o If any keys in set are missing, or become lost or stolen, the archival room doors is immediately
relocked (door lock mechanism replaced with new mechanism and new full set of keys engraved as
above)

7.1 During the conduct of study:

● Clinical study records are maintained in a separate, lockable room. Access to the room is controlled so that
only those study personnel who are assigned with responsibilities that require access to clinical records is
allowed. PI/Co-I/Medical study staff are authorized access to clinical study records.
● Closed, lockable, steel cupboards are utilized to store the records, to maintain security and protect them
from hazards. Each such room having the study cupboards is equipped with fire extinguishers and regular
pest control measures are undertaken.
● The study files are properly labeled for easy retrieval.

7.2 After completion of the study:

● A system for archival is developed and utilized so that storage location of all records is readily identifiable.
● The process of archiving documents is initiated once the database is locked, all the open issues are
resolved, reconciliation of document is done and the Sponsor has approved to archive the study documents.
● The study binders are properly labeled with study protocol number, binder name, name of Principal
Investigator, date of archival and the year till which documents need to be archived.
● The study documents are archived in a safe, lockable cupboard under lock and key in order to protect them
from dust, light, humidity, fungal attack, insects, rodents, gaseous emissions, fire and smoke. The cup-
board is also labeled with the identifiers such as Protocol Number, Principal Investigator’s Name, Archival
start and end date and List of study binders archived in that study cupboard.
● The archival room is regularly pest controlled, will have smoke detectors and identifiable fire extinguishers
with maintenance certificates.
● Any intent to move or change the archival location is communicated to the sponsor and IEC in advance.

8. REFERENCES
Nil
9. ANNEXURE/ ATTACHMENT
Nil