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What are common inspection observations regarding clinical trial contracts?
Dr Mira Antani
Regulatory GCP inspections have identified several gaps in the contracts. The inspectors have observed a lack of clarity with regards to:
• which tasks were defined in the contract
• tasks are sometimes partially described or not described at all
• which party is responsible for carrying out certain task(s) regarding generating, maintaining and archiving the relevant sections of the Trial Master File (TMF): emails, meeting minutes, system documentation such as trial-specific validation documents including documentation for user acceptance testing, specific codings, SOPs, etc.); Inspectors have seen incomplete documentation provided to the sponsor or documents that have been lost due to a lack of clarity concerning the duty of document retention;
• details concerning the retention and sponsor access to non-trial-specific documentation; for example, software/system validation documents, vendor SOPs, training records, issues log/resolutions in helpdesk/IT ticket system, etc.
• investigator’s control of their data and ownership of the data.
• location of data storage and control of this, for example use of cloud solutions.
• addressing potential system “down-time” and the preparation of contingency plans.
• The possibility of sub-contracting by the vendor is not always defined, including how the sponsor maintains oversight of contracted activities.
• The clinical trial applications are frequently incomplete regarding information on contracting out electronic data capture and/or randomization
What is the regulatory expectation for preventing mix-up of test and reference product for bioequivalence trials? Dr Ramesh Pandit
European Medicines Agency (EMA) recommends:
• the test and the reference product should be packaged during separate operations and should not be available simultaneously in the packaging area.
• during these operations not only should the test and reference products be kept separate, but also all material used for the packaging of each product (containers, labels) and the batch record documents. Material used for different products should not be available in the packaging area simultaneously.
• reconciliation should be performed for the quantities of IMP units, containers and labels introduced in the working area, used during the packaging, and remaining after these operations, before the area is cleared and before the packaged IMPs are released.
• the working area should be cleared of all IMP, packaging material and documents between the packaging operations of the test and of the reference product (line clearance). If packaging is performed for several trials successively line clearance should be ensured between each product and each trial.
• once the packaging has been completed for all products to be packaged for a given trial and the products have been released, the packaged test and reference products can be taken simultaneously into the packaging area for further operations (e.g., sorting the containers per subject number).
• critical steps should be controlled in-process by appropriately qualified and trained staff.
A standard operating procedure (SOP) should describe the packaging operations step by step, including the controls to be performed at each step and the responsibilities of each person involved.
What are regulatory expectations for digital trials? Purnima Solanki
Regulatory authorities expect the following during conduct of digital trials:
1. Optimal medical care, the rights and safety of subjects must be always ensured.
2. The IMP must be safely dispensed, ingested/administered, and returned.
3. The data recorded during the clinical trial must be credible and reliable.
4. The data protection requirements must be met in full.
For a clinical trial of an herbal product approved by the FSSI and used on patient along with standard treatment, what would be reporting process for serous adverse event? Dr Sreevasta
Any trial which is not for a new drug (as per New Drug Rules 2019) should comply ICMR 2017 guidelines. The Ethics Committee should receive AE/SAE reports and decide about compensation.
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