The document outlines the Site Initiation Visit (SIV) process, which includes preparation steps for sponsors and sites, training activities for staff, and the essential documents required for conducting research trials. It elaborates on the scheduling of SIV, shipment of supplies, and the training necessary to ensure compliance with study protocols. It concludes by highlighting the follow-up activities post-SIV and references for further information.

1. Activities conducted during SIV
Presented by – Manasi Dhamal, Mayuri Bhome, Dr. Geetu Mohan, Adil Shaikh

2. Content
 What is SIV?
 Preparation for SIV
 Activities conducted during SIV
 Essential Documents required
 References
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3. What is SIV?
 SIV :- Site Initiation Visit
 Once the site is selected, a Site Initiation Visit (SIV) is planned to provide
study-specific information & training to investigators and staff before
study start-up by CRA from sponsor/CRO .
 Once all FQ and SQV done and required documents are collected and
approvals are in place, sites can be initiated.
 The initiation process involves several steps.
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4. Preparation for SIV (1/4)
• Timing for Conduct of SIV
I
• Sponsor Preparation
II
• Site Preparation
III
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5. Preparation for SIV (2/4)
I. Timing For Conduct of SIV :-
 Before Patient enrollment.
 After all essential documents are in place.
 After supplies received.
 After Institutional Review Board(IRB) Approval.
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6. Preparation for SIV (3/4)
II. Sponsor Preparation :-
 Set a manually agreed-upon meeting time.
 Send prepared agenda with expected attendees.
 Send all Study-related materials in advance for
review.
 Send supplies.
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7. Preparation for SIV (4/4)
III. Site Preparation :-
 Review protocol and any other documents received by sponsor/CRO (i.e.
CRFs, IB).
 Become familiar with the study procedures.
 Confirm supplies received (i.e. Drug ,Binders, test tubes, Regulatory
binder, etc.
 Write down questions for sponsor/CRO when reviewing documents.
 Secure room.
 Ensure staff availability for the visit.
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8. Activities involved during SIV
SCHEDULED
SIV
SHIP SUPPLIES
SITE TRAINING
FOLLOW UP
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9. Activities involved during SIV (1/4)
 The PI will arrange a date and time as requested by the sponsor that is
convenient for all if not as many members of the clinical study team as possible.
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STEP 1 : SCHEDULED
SIV

10.  The following are shipped to site to be made available on the SIV date:-
 Study Protocol
 IP
 Other supplies such as lab kits
 Other relevant study materials
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STEP 2 : SHIP SUPPLIES
Activities involved during SIV (2/4)

11. Activities involved during SIV (3/4)
 During SIV, all site staff must be trained.
 Here are some of the required trainings :-
 Good Clinical Practice
 Study Protocol
 CRFs
 Study procedures
 IP handling and accountability
 PI and staff responsibilities
 Subject Safety
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STEP 3 : TRAINING

12. Activities involved during SIV (4/4)
 After the visit, the monitor will complete a
monitoring report for the sponsor and send a
follow-up letter to the site.
 Resolutions to any unresolved questions that came
up during the visit will also be included in the letter.
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STEP 4 : FOLLOW
UP

13. Essential Documents in SIV
Sr.
No.
Document Stage Filing Location
SMF TMF
1 Instructions for handling
of IP(s) and trial related
materials
Before Trial × ×
2 Shipping records of
IP(s) and trial related
materials
Before Trial × ×
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14. Essential Documents in SIV
Sr.
No.
Document Stage Filing Location
SMF TMF
3 Certificates of
Analysis(COA) of IP(s)
shipped
Before Trial ×
4 Trial Initiation
Monitoring Report (SIV
Report)
Before Trial × ×
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15. References
 https://prezi.com/n8t5isvqvrv_/site-initiation-visit/
 https://florencehc.com/blog-post/the-future-site-
initiation-visit-with-eisf-capabilities/
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