SCRS Site Management Module E6(R2) and (R3) Update
Description: SCRS Site Management Module E6(R2) and (R3) Update Supplement Source Documentation Section 4.9.0: The investigator should maintain adequate and accurate source documents and trial records that include all pertinent observations on each of
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slide1. SCRS Site Management Module E6(R2) and (R3) Update Supplement Source Documentation<br>
slide2. Section 4.9.0: “The investigator should maintain adequate and accurate source documents and trial records that include all pertinent observations on each of the site’s trial subjects. Source data should be attributable, legible, contemporaneous, original, accurate, and complete. Changes to source data should be traceable, should not obscure the original entry, and should be explained if necessary (e.g., via an audit trail).”
Note the adoption of the ALCOA (attributable, legible, contemporaneous, original, and accurate) acronym for creating adequate documentation which now becomes ALCOA-C as Complete is added to the source data requirements. Source records must be complete – including medical history records when applicable. E6(R2) Updates<br>
slide3. Section 2.12.3: "The investigator should have timely access to and be responsible for the timely review of data, including relevant data from external sources."
ICH E6(R3) emphasizes timely access and review of all trial data by the investigator, including external and digital data sources. This includes ensuring that eSource systems, digital platforms, or third-party vendors do not impair the investigator’s ability to control, verify, and certify the source data.
Considerations include:
Procedures to confirm accuracy, completeness, and integrity of electronic records.
Access to audit trails and version histories for key data points.
Real-time or near-real-time data review workflows to mitigate delayed error detection. E6(R3) Updates<br>
slide4. This is to certify that:
(insert name)
Has completed reviewing the Topic: ICH E6(R2) and (R3): Guideline for Good Clinical Practice, Source Documentation Module Update Supplement, on:
(insert date)
Disclaimer: SCRS does not certify, qualify, endorse, represent or warrant that any clinical trial Investigator or clinical trial site personnel that has completed this Information Program are competent to work on any particular clinical trial or clinical trials generally or are competent to oversee others during clinical trial execution. Certificate of Completion<br>
slide2. Section 4.9.0: “The investigator should maintain adequate and accurate source documents and trial records that include all pertinent observations on each of the site’s trial subjects. Source data should be attributable, legible, contemporaneous, original, accurate, and complete. Changes to source data should be traceable, should not obscure the original entry, and should be explained if necessary (e.g., via an audit trail).”
Note the adoption of the ALCOA (attributable, legible, contemporaneous, original, and accurate) acronym for creating adequate documentation which now becomes ALCOA-C as Complete is added to the source data requirements. Source records must be complete – including medical history records when applicable. E6(R2) Updates<br>
slide3. Section 2.12.3: "The investigator should have timely access to and be responsible for the timely review of data, including relevant data from external sources."
ICH E6(R3) emphasizes timely access and review of all trial data by the investigator, including external and digital data sources. This includes ensuring that eSource systems, digital platforms, or third-party vendors do not impair the investigator’s ability to control, verify, and certify the source data.
Considerations include:
Procedures to confirm accuracy, completeness, and integrity of electronic records.
Access to audit trails and version histories for key data points.
Real-time or near-real-time data review workflows to mitigate delayed error detection. E6(R3) Updates<br>
slide4. This is to certify that:
(insert name)
Has completed reviewing the Topic: ICH E6(R2) and (R3): Guideline for Good Clinical Practice, Source Documentation Module Update Supplement, on:
(insert date)
Disclaimer: SCRS does not certify, qualify, endorse, represent or warrant that any clinical trial Investigator or clinical trial site personnel that has completed this Information Program are competent to work on any particular clinical trial or clinical trials generally or are competent to oversee others during clinical trial execution. Certificate of Completion<br>