17 Sep Highlights from MHRA GCP Symposium in Sep. 2018
The MHRA GCP Inspectorate Symposium was held recently in Leeds, UK. There was an extremely positive atmosphere and great opportunities to discuss with the inspectors during the day.
The topics covered included quality systems and effective CAPA, computer system validation, handling of safety data and reference safety information (RSI) , investigational medicinal products (IMP) handling and unblinding issues, update on the strategic review of GCP inspections in light of new technologies in clinical trials.
Below are some highlights from the symposium:
Corrective Action and Preventive Action (CAPA):
In order to make an adequate CAPA, it is important to make a thorough root cause analyse. The timelines for CAPA implementation should be realistic and achievable. The organisation should ensure that there are robust mechanisms in place for oversight of the CAPA implementation. If the CAPA needs to be changed according to the inspection report, it is important to contact the inspector and document the reason and rationale for changes. Do not be afraid to revisit the CAPA, if it is not working.
Reference Safety Information (RSI):
It should be made clearly to the authority and involved parties/internal staff about which document should be used as RSI. The RSI can be the Investigator Brochure (IB) or the Summary of Product Characteristics (SmPC). The location of RSI should be indicated in the cover letter to the authority.
Changes to RSI are always substantial and they can only be implemented after the authority’s approval. Ensure that the currently approved RSI is used. The RSI approved at the time of the occurrence of a serious adverse reaction (SAR) (i.e. SAR onset date) should be used to determine expectedness of a SAR and its follow-up. Expected SAR must be occurred at least more than once in clinical setting and related to the IMP. A rationale should be provided to support the the expectedness.
IMP and unblinding:
We all agree that correct use of IMP is important for patient safety. However, there are several serious breaches involving incorrect use of IMP such as wrong IMP kit was dispensed, wrong storage (e.g. no temperature monitoring or storage outside temperature ranges), inadequate labelling, IMP was given to non-trial subject, use of expired IMP etc. It is crucial that the site staff is well trained in handling of IMP. The IMP should be stored securely and only be accessible to the site staff which is involved and trained in the trial.
The IMP labelling and packaging should be at low risk for medication error e.g. use of distinguishable colours for different IMP strengths. An IMP risk assessment and mitigation should be made.
When IRT is used for randomisation, ensure that unblinded information is handled correctly by the system. Only authorised unblinded person has access to unblinded information during the trial. In addition, unblinded staff must have process in place to prevent accidental unblinding of blinded person; e.g. use of locked safety box for storage of unblinded information.
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