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SOP TITLE: Archiving Trial Data SOP

SOP Version 01
No:
Date:

SOP No:

Version: 1

Effective Date:
Standard Operating Procedure

Title: Archiving Trial Data SOP

NAME SIGNATURE DATE


PREPARED BY
REVIEWED BY
QA UNIT
AUTHORITY
APPROVAL
AUTHORITY

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SOP TITLE: Archiving Trial Data SOP

SOP Version 01
No:
Date:

1.0 PURPOSE/ INTRODUCTION

1.1 PURPOSE
All trial data must be kept so that the data can be accessed after the trial is finished. This
may be necessary in the event of unexpected side effects after the trial drug has been
approved. It is the responsibility of the Sponsor and the Principal Investigator to keep
these records.
The ICH GCP Guidelines are specific about which documents are essential for the
conduct of a clinical trial and which of these must be located in the Investigators’ trial
file. The ICH GCP Guidelines state that essential documents be retained ‘ until at least 2
years after the last approval of a marketing application in an ICH region’. This is not
expected to be sole responsibility of the Investigator, ‘it is the responsibility of the
Sponsor to inform the Investigator/Institution as to when these documents no longer
need to be retained.

1.2 INTRODUCTION
Archiving is the act of storing and preserving non-active records with an enduring
value .the archivist coordinates and ensures quality storage and easy retrieval of the
records.

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SOP TITLE: Archiving Trial Data SOP

SOP Version 01
No:
Date:

2.0 SCOPE/RESPONSIBILITY
2.1 This procedure applies to all the clinical trials and clinical trial laboratory work
conducted at the site.
2.2 All documentation as defined in ICH GCP guidelines must be retained until
notification from the Sponsor, in fire and theft proof facilities. Archived materials should
include all related paper work such as:
- Trial site files
- Consent forms
- Patient log and details
- Case report forms

2.4 Responsible Personnel

DCTC: -
- Trust Research Laboratories – Director
- Coast Geographical Research Centre – Director

HCR: - Research Laboratories.

CTC staff: -
- Laboratory Clinical Trial Group
- Scientific Staff
- Clinical List
- ICT Manager
- ICT Data Administrator
- ICT Records Staff

CTC staff will ensure all relevant clinical trial documentation is properly maintained and
is accessible for as long as required in accordance with ICH GCP guidelines.

3.0 DEFINITIONS
3.1 Archive – A place where Non-active records are stored.
3.2 ‘archive’ – Non-active records.
3.3 DCTC - Director of Clinical Trials Centre

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SOP TITLE: Archiving Trial Data SOP

SOP Version 01
No:
Date:

3.4 HCR - Head Clinical Research


3.5 CTC - Clinical Trial Centre
3.6 ICT - Information Communication Technology
3.7 SOP - Standard Operating Procedure
3.8 ICH - International Conference for Harmonization
3.9 GCP - Good Clinical Practice

4.0 SPECIMEN
N/A
5.0 EQUIPMENT/MATERALS

5.1 Archive room


5.2 Storage boxes
5.3 Documents
5.4 Files
5.5 Shelves
5.6 De-humidifier
5.7 Air conditioning
5.8 Fire Alarms

6.0 METHODOLOGY

6.1 Principle
6.1.1 Archiving is done as various departments bring in their records.
6.1.2 The archives are analyzed to confirm they’re enduring value.
6.1.3 Ensure numerical filing of the boxes
6.1.4 File weeding.
6.1.5 File census

6.2 Procedure
6.2.1 File archiving

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SOP TITLE: Archiving Trial Data SOP

SOP Version 01
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Date:

6.2.2 Receive non-active files


6.2.3 Log them in the system database.
6.2.4 Sent copy to creating department for confirmation.
6.2.5. Order for storage boxes from the stores
6.2.6. Prepare storage boxes
6.2.7 Arrange the records avoiding excess loading of the boxes
6.2.8. Note the contents.
6.2.9 Prepare labels and label the storage boxes
6.2.10. Then file boxes on the shelves
6.2.11. Numbering is done

6.3 Retrieval
6.3.1 Receive a request from the users.
6.3.2 Log in the requests.
6.3.3 Print the list.
6.3.4 Identify the location name
6.3.5 Identify the box number then retrieve the file.

6.4 Cause of poor Archiving


6.4.1 Miss filing.
6.4.2 Incorrect labeling

7.0 APPENDICES:
7.1 Submission Log
File brought by Type of record Department Date brought Received by
in

7.2 Label
E.g. sample of the labels

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SOP TITLE: Archiving Trial Data SOP

SOP Version 01
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Date:

BOX 001

8.0 REFERENCES:
8.1 Records centre manual.
8.2 Sop links -Sop11: study files and filing
8.3 ICH GCP (1996)

9.0 DOCUMENT CHANGE HISTORY


This section is to be completed by the Quality Management or designee
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Original: Dated: SOP No.: No.


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SOP TITLE: Archiving Trial Data SOP

SOP Version 01
No:
Date:

This template document has been freely provided by KEMRI-Wellcome


Trust via The Global Health Network. Please reference The Global
Health Network when you use it, and share your own materials in
exchange. www.theglobalhealthnetwork.org.
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SOP TITLE: Archiving Trial Data SOP

SOP Version 01
No:
Date:

SOP Review and Updating Logs

DATE NAME OF REVIEWER SIGNATURE

DOCUMENT COPY CONTROL

SOP DISTRIBUTION
DATE SECTION RECEIVED BY

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Health Network when you use it, and share your own materials in
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SOP TITLE: Archiving Trial Data SOP

SOP Version 01
No:
Date:

Training Documentation Log for SOP Files

Supercedes:
Copy Number 1 of Effective Date:
Standard Operating Procedure
Title: SOP of SOPs
NO. DATE NAME SIGNATURE

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SOP TITLE: Archiving Trial Data SOP

SOP Version 01
No:
Date:

This template document has been freely provided by KEMRI-Wellcome


Trust via The Global Health Network. Please reference The Global
Health Network when you use it, and share your own materials in
exchange. www.theglobalhealthnetwork.org.
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