Reference:USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013 III B. 3.

Document information
Reference	USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013
Validity area	USA
Scope(s)	G
Document name	FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
Version / Revision	Aug-2013
Status	Current
Document type	Official recommendation
Language(s)	EN
Description	Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Guidance for Industry
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 4 — Unit 4.3.3
Scope	G
Document part	III B. 3.
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Source data verification, Remote SDV, Monitoring, Case report form, Source documents
Comment	Alternative monitoring techniques including remote SDV

Content

III. OVERVIEW OF MONITORING METHODS B. Examples of Alternative Monitoring Techniques […] 3. Source Data Verification and Corroboration The sponsor should consider the quantity and types of source data that need to be verified against CRFs or corroborated against other records (e.g., review of medical record to corroborate a subject’s response of “no hospitalizations” since the previous visit on a CRF) during the sponsor’s identification of critical data and processes or in the risk assessment, or both. The sponsor should include a description of the quantity and types of source records to verify or corroborate in the monitoring plan. The sponsor should consider which source records are likely to provide the most meaningful information about a subject’s participation and the CI’s conduct and oversight. For example, for a particular study, there may be minimal benefit in comparing 100% of the source data for each subject to the CRFs for each study visit. Rather, it may be sufficient to compare the most critical data points for a sample of subjects and study visits as an indicator of data accuracy. Similarly, for a particular study, although collection of all concomitant medications, body temperature, and body weight are required by the protocol and are documented in the medical record and transcribed to a CRF, they may not be identified by the sponsor as critical data, because a small error rate in those variables would not affect the outcome of the trial. In the absence of information indicating potential concerns with the data (e.g., sites with data anomalies, inconsistent data), source document verification or corroboration of these non-critical data may not provide significantly useful information to the sponsor.