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Q of the week

Q: Do clinical trials ever go wrong?

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A test to check for cancer of the cervix, the opening to a woman's womb. It is done by removing cells from the cervix. The cells are then prepared so they can be seen under a microscope.

Quality Assurance and Audits
  1. According to GCP is there any difference between QA and QC?
    According to ICH GCP
    1.46 Quality Assurance (QA)
    All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).
    1.47 Quality Control (QC)
    The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.
  2. During audit, what is the procedure to select sample number of case report forms (CRFs) for source data verification?
    There does not appear to be a consistent approach to CRF selection within the industry as different methods are being used by the companies. Some use square root of number of CRFs plus one (usually using total number of enrolled subjects - this can either include or exclude screened subjects depending on the company). Some define a minimum range, for example 3-5 CRFs. Some companies do 100 per cent Source Data Verification (SDV) for consent forms and then 100 per cent of SDV for 10 per cent of total CRFs. At the time of report audit, all primary efficacy data and adverse events would be audited 100 per cent for all patients randomised and/ or enrolled. Some companies only allow one day for an audit for one auditor, and in this case it would be difficult to review more than three CRFs in adequate detail unless the study was very simple. If there are particular problems then it might be necessary to extend the review to more CRFs, or if there are so many discrepancies on the first two CRFs that there is no point reviewing any more as the recommendation would be for someone to re-monitor all CRFs.
  3. When should be the Audit certificate will be issued is it after completion of QA audit or after resolution of all queries raised by Quality Assurance?
    It is not mandatory to issue the audit certificate after completion of site audit. Audit certificate is issued when it is required by the applicable law/regulations of the country the audit is being performed or requested by the sponsor for contracted audits. In practice, you can issue audit certificate along with the audit report. ICH E3 guidelines for Clinical Trial Report require an audit certificate to be appended, if available (appendix 16.1.8).



Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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