STANDARD OPERATING PROCEDURE FOR ARCHIVING, RETRIEVING, RETENTION, AND DESTRUCTION OF RECORDS AND OTHER STUDY-RELATED MATERIAL

1.0 OBJECTIVE

1.1 To lay down a standard procedure for archiving, retrieving, retention, and destruction of records and other study related material.

2.0 SCOPE

2.1 This SOP shall be applicable for archiving, retrieving, retention, and destruction of records and other study related material in Department of Quality assurance (QAD).

3.0 RESPONSIBILITY

3.1 Archivist

3.2 Head- QA

3.3 QA Personnel (QAP)

4.0 DEFINITIONS

4.1 Nil

5.0 PROCEDURE

5.1 Procedure for Archiving

5.1.1 All the essential documents held within the respected departments are appropriately archived through the transfer of all records to the Archivist by filling archive submission form as per format no. F……………………….

5.1.2 All records are stored securely under custody of Archivist. A Data archiving log, as per format no. F……………………. and format no. F…………………… for the documents and material archived.

5.1.3 Archiving occurs as soon as possible after completion of a study, typically within 30days after completion of a study/ completion of logbooks and format books.

5.1.4 In case of documents to be reviewed/revised shall be archive within 30days after due date of review/revision.

5.1.5 All archived material should be stored in a suitable place. The archival location should be restricted to only appropriately delegated individuals, and appropriate quality checks should be in place to ensure the preservation of the archive. This would include a Risk Assessment for fire, environmental damage, pest control, and ongoing monitoring of these risks. This store may be an internal storage area or a commercial archiving store.

5.2 Procedure for Retrieving

5.2.1 Archivist has a responsibility to allow the access to the archived data on data retrieval request form as per format no. F………………………..

5.2.2 Whenever an item is retrieved from archive, A data retrieve log, as per the format no. F…………………. and format no. F………………….. shall be maintained by Archivist in which date, item and person retrieving the item should be documented, together with the date returned to archive of documents retrieved.

5.3 Procedure for Retention and destruction

5.3.1 In accordance with COMPANY Records Management Policy, study documents shall be retained by Archivist for 5 years after the study has finished. This is deemed a sufficient period of time to allow for audit and inspections by regulatory authorities and sponsors. The Archivist maintains archived records in a safe and secure location.

5.3.2 A data retention and destruction log, as per format no. F………………….. and format no. F…………….. for the documents and material respectively shall maintained within Archivist.

6.0 ENCLOSURES

6.1 Formats

Sr. No.	Format Title	Format No	No. of Pages
	Archive submission form	F……………………..	01
	Master index for file location	F…………………….	01
	Master index for material location	F……………………..	01
	Document destruction record	F…………………….	01
	Material destruction record	F……………………..	01
	Retrieval request form	F…………………….	01
	Document retrieval and return record	F……………………..	01
	Material retrieval and return record	F…………………….	01

7.0 ABBREVIATIONS

7.1 SOP- Standard Operating Procedure

7.2 QAD- Department of Quality Assurance

8.0 REFERENCES

8.1 In-house

9.0 REVISION HISTORY

9.1

Nil
                                                             END OF THE DOCUMENT

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