Archival

 

All essential documents related to clinical trial must be archived so that the data is accessible after the trial is completed. The study documents may need to be accessed in future due to regulatory reasons such as audits, further clarifications to data submitted for regulatory approvals, for additional data requirements from regulatory bodies to assess drug safety.

The International Conference on Harmonization of Good Clinical Practice (ICH GCP) guidelines has specified the list of essential documents which is mandatory to be archived at the investigator site (ICH-GCP 4.9.4).The time period for archival should be as specified by the local regulatory requirement or as per sponsor requirement. (ICH-GCP 4.9.5)

Features of our Archival Facility:

  •  Controlled environment: The facility is strictly dedicated for archival of study documents. It is ensured that the archiving facility is secure, environmentally controlled, i.e. fire protection without water sprinkler systems, water protection for humid conditions.

  •  Record Keeping: Archived material is stored in legible conditions, with fax thermal paper copied to standard paper.

  • Confidentiality: The access to archival facility is strictly restricted to designated individuals responsible for the archival or to regulatory authorities. Data is stored in compact units in a way to ensure that confidentiality of participants remains protected. All storage arrangements (cupboards, racks) would be labeled appropriately and a log maintained for the same. 
News
CRF at ERS 2016 London
7 of the 12 abstracts submitted were selected at t
CRF at ERS 2015 Amsterdam
9 of the 13 abstracts submitted were selected at t
Events
ICONIC 2016
Chest Research Foundation, Pun...
Programs management
     Programs management
Loading ...Loading ...