Prior to initiating trial related activities at the site, the principal investigator of the site should ensure preparedness, as below:

Approvals and Agreements:

• For a regulatory clinical trial, an approval from Central Drugs Standard Control Organization (CDSCO) is mandatory.
• Approval or favourable opinion from the ethics committee of the site.
• AClinical Trial Agreement, signed between the site and the sponsor / funding agency / monitoring agency, etc. as required.

Site-specific processes:

• Site preparedness: It is imperative that the site is set up before commencing participant recruitment. This includes:
  • A review of the facilities
  • Hiring the site / project team
  • The Investigator Site File (ISF) should be prepared and available at the site.
  • The Investigational Product and other trial related supplies must be available at the site.
  • The Case Record Forms (CRF), Informed Consent Documents (ICD), etc. must be available at the site.
• Any other equipment required to conduct the trial (example, tablets for data entry or computers, etc.) must be available at the site.
• Site staff training.
• The sponsor, principal investigator and/or CRO must ensure that the site has received the allocated funds for the conduct of the trial.
• If the trial involves shipment of biological samples, then, arrangements for their transport to the designated laboratory have been made.
• The sponsor must ensure that all relevant electronic systems have been set up at the site.

To ensure quality and uniformity in performance and compliance with all applicable guidelines and regulations, it is essential that there are a set of documented SOPs available at each participating site for a clinical trial. The SOPs should be aligned to the needs of the trial to be conducted, and the site as well.

Some of the recommended SOPs are:

1. Project Management Plan (details of the operational plan including strategies for recruitment, retention strategies, contingency plan, etc.)
2. SOP for Data Management / Data Management Plan
3. SOP for Quality Management
4. SOP for Risk Management
5. SOP for Pharmacovigilance / Pharmacovigilance Plan
6. SOP for Site-Staff Training / Training Plan
7. SOP for Trial Master File and Investigator Site File
8. CRF Completion Manual
9. SOP for Investigational Product Management (handling, storage, accountability, retrieval, destruction, etc.)
10. SOP for Safety Reporting
11. SOP for Trial Close-Out / Site Close-Out
12. SOP for Archival

In addition to the above, all relevant logs and forms should be made available at the site.

References

• New Drugs and Clinical Trial Rules, 2019, G.S.R. 227(E), Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, available online (last accessed on 03.04.2019).
• Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online (last accessed on 26.02.2019).