Redacting Personal Data/CCI In EU Clinical Trial Inspection Reports On The Agenda
Executive Summary
Work is expected to start this year on developing guidance for the EU member states on how to redact clinical trial Inspection reports to protect personal data and commercially confidential information under the new Clinical Trials Regulation.
Guidance is to be developed this year on conducting clinical trial inspections in the EU and on the personal data and commercially confidential information (CCI) that will need to be redacted from inspection reports under the EU Clinical Trials Regulation, according to the European Medicines Agency.
The guidance document relates to a provision in the CTR that will expand the scope of information that the EMA will publish compared with its current clinical data publication policy. It is among a raft of items covering good clinical practice on the agency’s GCP Inspectors Working Group work plan for 2017.
Documents published under the agency’s current clinical data publication policy relate to the clinical overview, clinical summaries, clinical study reports and the anonymization report. The CTR (Regulation (EU) No. 536/2014), on the other hand, will require the publication of all clinical trial-related information generated during the trial’s life cycle, for example, the protocol, assessment and decision on trial conduct, summary of trial results including a lay summary, study reports, inspections, etc. The CTR is expected to come into effect in October 2018.
The GCP IWG said it was also interested in preparing Q&A documents, as required, to clarify the inspectors’ expectations with respect to certain processes and procedures, with a particular focus on data protection.
Other actions on the GCP IWG’s 2017 schedule that relate to the CTR include helping to finalize a guidance document on risk-proportionate approaches in clinical trials. This document, which was released for consultation between June and September last year, deals with applying less stringent rules (i.e., risk adaptations) in specific areas mentioned in the CTR, such as: safety reporting, traceability of the investigational product, trial monitoring and content of the clinical trial master file. (Also see "Commission Consults On New Risk-Proportionate Approaches Under EU Clinical Trials Regulation" - Pink Sheet, 2 Jun, 2016.)
The agency also plans to release for consultation the three new GCP documents that have already been drafted:
- Guidance for the appointment of a lead EU member state for the management of serious breaches;
- Guidance for clinical trial sponsors on what is expected to be reported as a serious breach; and
- Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials.
In addition, the EMA plans to finalize the revision of the following guidelines:
- Detailed guidelines on good clinical practice specific to advanced therapy medicinal products; and
- Recommendations on the qualifications of inspectors verifying compliance in clinical trials with the provisions of good clinical practice.
Implementing the GCP inspections program for 2017, the working group says, will involve:
- defining in advance the number of GCP inspections to be requested in 2017;
- ensuring a broad coverage of product types, therapeutic areas/indications, target population, sponsors/CROs/vendors, studies and sites;
- proactively selecting the focus areas with respect to issues such as indication, population, geographical location of sites, recruitment rates, size of sponsor and CRO, and the general trends to be followed in the period 2017-2018; and
- ensuring that diverse geographical regions are selected for inspection, including third countries from which a substantial amount of clinical trial data in MAAs is derived.
Liaising with international partners in a bid to save resources and reduce duplicating inspections is also on the work GCP IWG 2017 work plan. For example, the agency said it would work on progressing the various GCP initiatives it had established with regulators in the US and Japan.
In addition, the working group plans to spend some of 2017 helping candidate EU countries (e.g., Albania, Montenegro and Turkey) and potential candidates (Bosnia and Herzegovina and Kosovo) develop their GCP inspection roles.
From the editors of Scrip Regulatory Affairs.