Recently, FDA issued a new draft guidance document through their online email notification system regarding proposed revisions to the ICH GCP Guidelines for Good Clinical Practice. The draft guidance, titled “E6 (R2) Good Clinical Practice,” is currently in what FDA calls “Step 2 of the ICH Process,” which means that it was released for feedback by the ICH Steering Committee on 11 June 2015 to the regulatory authorities of the ICH regions (the European Union, Japan, the USA, Canada, and Switzerland). This is very exciting news for the clinical research community, as the ICH GCP Guidelines have not been updated since they were originally released nearly 20 years ago in 1996.
We have taken some time to review the proposed changes and wish to share a summary of what is proposed with the rest of the clinical research community. Overall, the changes appear to be modest. Mostly, there have been some small additions to the document that seem to aim at addressing modern day technologies and real life practices that play a role in day to day activities in our industry, such as electronic records and remote monitoring to name a few.
Below you will find a bullet point list of all the proposed changes, and a brief description of what they entail:
- 1.11.1 – new definition added for “certified copy”
- 1.38.1 – new definition added for “monitoring plan”
- 1.39 – new definition added for “monitoring report” and a note the outcomes of any centralized monitoring should also be reported
- 1.60.1 – new definition added for “validation of computerized system”
- 2.10 – statement added that expands the concept of recording, handling, and storage of trial information to include paper and electronic records
- 4.2.5 and 4.2.6 – new sections regarding investigator responsibility of supervising those individuals whom they delegate tasks at the trial site, as well as any services delegated to any other parties
- 4.9.0 – new section that specifies that source documents and trial records should follow ALCOA (attributable, legible, contemporaneous, original, accurate, and complete)
- 5.0 – an entirely new section pertaining to Quality Management for Sponsors that is grounded in risk-based approaches. This section includes sub-sections on Critical Process ad Data Identification, Risk Identification, Risk Evaluation, Risk Control, Risk Communication, Risk Review, and Risk Reporting.
- 5.2.1 – statement added to section about CROs that indicates the Sponsor should ensure oversight of any duties carried out by a CRO on the Sponsor’s behalf
• 5.2.2 – added a sentence that clarifies that any duties transferred to a CRO should be specified in writing, and the Sponsor should document approval of any subcontracting of trial-related duties and functions by a CRO
- 5.5.3(b) – expanded the section pertaining to Sponsors maintaining SOPs for electronic data capture systems they use that includes measures that parallel part 11 compliance
- 5.5.3(h) – new item regarding data integrity when computerized systems undergo changes, upgrades, or migration of data
- 5.18.3 – added an entire new section pertaining to risk-based monitoring, noting on-site and centralized monitoring procedures
- 5.18.6(e) - added a new item under the monitoring report section that specifies that monitoring results should be provided to the Sponsor in a timely manner, documented in sufficient detail to allow verification of compliance with the monitoring plan
• 5.18.7 – added a new section that specifies that Sponsors should develop and use a monitoring plan
- 5.20.1 – added a paragraph about managing non-compliance when learned of by the Sponsor
- 8.1 – the introductory section regarding essential documents has been expanded
We hope you find this summary helpful. We are excited for these updates, and would love to hear your opinions on what they mean for us as an industry. Do you feel these adequately address needed changes to the document? Or perhaps, do you feel they are too extensive or unnecessary?