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SITE INITIATION Checklist The purpose of this document is to provide the Lead Site with a system for performing study initiation visits. Instructions: The following items should be addressed when.

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Related links form

VA 22-0830 2010 VA 22-0848 2012 VA 22-0976 2017 VA 22-0989 2018

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The length of an initiation visit may vary ing to the complexity of each study, but a typical initiation visit lasts about 7 hours.

When conducting the site initiation visit (SIV): Review the protocol in detail. Review instruction on any specialised procedures such as diagnostic tests and special computer programs. Receive direction for Case Report Form (CRF)/electronic CRF completion & safety reporting. Define source documents.

The following pre-requisites should be completed prior to the site initiation visit: protocol and consent have been reviewed and approved by any required Scientific Review, the DSMB, and the IRB; the case report form and data collection system have been finalized; the Manual of Procedures (or set of study specific ...

This type of visit has three goals: 1) to orient and train staff on the protocol and study related processes; 2) to confirm readiness for study implementation; 3) to identify additional requirements that ought to be satisfied prior to site activation and subject recruitment.

Once the site is initiated, it is important that the research team notifies all parties involved in the study. Internal supporting ancillary departments may require subsequent kick-off meetings to discuss study logistics.

Site initiation occurs prior to site activation. Typically, the sponsor or clinical research organization will conduct a site initiation visit after the Institutional Review Board approves the clinical research study at that site and the clinical research study agreement is signed.

Information For Step 1: Discovery and Development. Step 2: Preclinical Research. Step 3: Clinical Research. Step 4: FDA Drug Review. Step 5: FDA Post-Market Drug Safety Monitoring.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232