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ICH GCP Essential Document Checklist Study Number: Status: Study Type: Clinical Drug Trial; NonDrug Subject Research (ICF); Usual Regulatory Binder Items: Section Numbers PreActivation; Active Study;.

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ing to the ICH Guideline, Section 1.23, 'essential documents' are defined as: 'Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced'.

ICH GCP groups essential documents into three sections based on the expected timeframe of their generation: before the clinical phase of the trial, during the clinical conduct, and after the completion or termination of the trial.

See WHO GCP Principles 1: Ethical Conduct; 2: Protocol; 4: Benefit- Risk Assessment; 5: Review by IEC/IRC; 7: Informed Consent; 8: Con- tinuing Review/Ongoing Benefit-Risk Assessment; 11: Records; 12: Confidentiality/Privacy.

The informed consent form, which is a legal document, must include 20 ICH-required elements (section 4.8. 10 of the GCP guidance). They include the purpose, duration, risks, benefits, costs and additional expenses of the trial; a description of the trial procedures; alternative care options; and volunteers' rights.

International Conference on Harmonization (ICH) Good Clinical Practices (GCP) guidance defines essential documents as “those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced.

The various documents are grouped in three sections ing to the stage of the trial during which they will normally be generated: 1) before the clinical phase of the trial commences, 2) during the clinical conduct of the trial, and 3) after completion or termination of the trial.

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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