This document outlines the steps for conducting a clinical trial and conducting a site qualification visit. It discusses preparing essential documents, selecting an investigator and site, conducting the qualification visit to assess the site's capabilities, and reviewing requirements like the protocol, informed consent, reporting procedures, documentation, facilities, staff experience, and regulatory approvals. The qualification visit confirms the site's readiness before initiating a clinical trial.

1. Prepared by: Vinendra Parmar
Clinical Research Associate
Site Qualification Visit

2. Flow steps for conducting clinical trial.
1. Preliminary discussion with sponsor
2. Agreement with sponsor
3. Prepare draft protocol & IB
4. Potential PI & feasibility (Is PI interested??)
5. agreement with PI
6. Site Qualification visit
7. Finalized protocol and essential documents
8. Regulatory submission & approval
9. SIV (site initiation visit)
10. Subject enrollment
11. Monitoring and audit visits
12. Close out
13. Payment
14. Clinical trial report
15. Study completion and archive study file

3. • Clinical monitor perform qualification visit for site eligible
investigator.
• Once potential site is selected for a particular clinical trial, the
monitor will schedule and confirm a site qualification visit with PI
and research team.
• Confirmation will be sent by telephonic, fax or email.
• Monitor assure that the site has received all required study document
prior to visit:
– Draft protocol
– Non-disclosure confidentiality agreement

4. Check list for conduct site qualification visit:
1. Protocol and study procedure
2. Informed consent
3. Source documents
4. Source data verification
5. AE/ SAE reporting
6. Monitoring and Audits
7. Translation requirements
8. Financial aspect
9. Subject insurance
10. Ethics committee requirement
11. Investigator and trial staff experience
12. Pharmacy
13. Storage area and study specialist
14. Laboratory
15. Archival facility

5. • Protocol and study procedures:
Overview of draft protocol
Investigator question regarding protocol
Safety of subject
• Informed consent
As per schedule Y
Audio-video recording and its storage
Adequate space for informed consent procedure
Training will be done during SIV
Space for Physical and vital examination
Site SOP for ICP…..(if!!!)

6. • Source documents
Electronic or paper documentation
Medical history, lab reports, and all patient records.
• Source data verification
Monitors, auditors, and sponsor personnel.
• AE/ SAE reporting
Reporting of AE/ SAE according to regulatory requirement.
Site SOP (if…!!!)

7. • Financial aspect
PI fees, CRC fees, EC fees and Research committee fees.
(if site is potential for recruiting subject than it will be
negotiable after discussion with ECTS Team)
• Subject Insurance
Company and validity
• Subject compensation

8. • Ethics committee requirement
As per schedule Y quorum fulfilled
EC SOP, EC meeting, day of submission of essential
document, EC fees, Research committee fees (including
any amendment).
• Investigator and Trial staff experience
PI clinical trial experience?
Regulatory audits?
GCP training?
Recruitment procedure?
PI experience particular trail and patient pool.
What is difficulty for recruiting?
Withdrawal of subject and loss to follow up ??

9. • IP storage facility
Separate room???
Lock and key cupboards, units, cabinet??
Temperature and humidity maintain??
IP dispensing/ accountability?
• Laboratory
Central lab (NABL and CAP accredited)
Local lab (any emergency!!!)
Lab reference range
CV of lab head.

10. • Storage area & study specific equipment
Study specific equipment like ECG machine, height scale,
weighing machine, BP instrument, refrigerator and centrifuge
(calibrated???)
Printer, scan and fax (if required)
• Archival facility
Separate room
Fees for archival
• Ambulance facility
any emergency?
• Example:

11. Thank You..!