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SOURCE DATA VERIFICATION CHECKLIST Study No.: Site No.: Data Checked Date of Procedure/Visit Patient Enrolment & Identification Patient Demographics DOB: Sex: Weight (If applicable) Height (If.

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Source data are contained in source documents (original records or certified copies). Source Documents are those documents where data regarding study subjects are first recorded and serve as the basis for the information submitted to the Sponsor on the case report forms.

Monitoring of clinical trials is a federally mandated responsibility of trial sponsors and a core offering of contract research organizations (CROs) that is crucial to the validity of clinical research.

SDV is a crucial component of a clinical study to ensure the quality and integrity of the data. Still, it should be done in a way that maximizes the benefits while reducing the costs. RBM strategies, such as SDR, can help hone in on high-risk areas that require additional monitoring.

Subject safety and reliability of data are paramount in clinical research. This blog outlines what auditors look for when performing source data verification (SDV) and source data review (SDR) during routine investigator site audits.

SDV is used to confirm that the source data is accurate and complete as it is collected, stored, shared, and analyzed. It helps ensure that your data will be reliable and can be depended upon for decision-making during your clinical trials.

While source document verification (SDV) aims to compare recorded data against the source documents to ensure a match, the purpose of source document review (SDR) is to ensure the quality of the source documentation itself.

Source data verification predominantly detects random errors that likely have little impact on the results of clinical trials. Source data review is the review of source documents in relation to the clinical conduct of the protocol.

By definition, source data verification is the process of ensuring that the data reported for analyses accurately reflect the source data at the clinical trial site, a comparison of source data against the CRF data (transcription errors).

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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