Bioequivalence and Bioavailability Forum

Dear drgopal,

❝ Do we still require a Pathologist to countersign the reports? Is it absolutely necessary or our our technician's signature in the reports (after taking printout from the instruments) is sufficient?

❝ Can the Physician/Investigator (medicine graduate only) can certify or it has to be certified by a relevant specialist?

❝ What is the regulatory requirement?

The regulatory requirement will be purely National...

On a GCP point of view and IMHO: you don't need a cardiologist's signature on an ECG if your investigator or another physician reviewing the ECG is qualified both by training and experience. Regarding chest X-rays if they are done externally you should get a report along with the slide, with an interpretation from a specialist. If the X-ray is done internally IMHO you don't need a specialist if your investigator/physician reviewing the ECG is qualified. This qualification should be documented.

Regarding lab reports: I may be influenced by the French regulations in this matter, but I would recommend a signature by a pathologist. The investigator/physician is qualified to interpret the result, but the role of the pathologist, besides checking that everything went well during the analysis (which includes results of QC samples but also equipment maintenance etc.) is also to check the credibility and consistency of the various results for the subject at this visit (e.g. if SGOT is 5 IU/l and SGPT is 400 IU/L, something probably went wrong somewhere and the test should be repeated, even if the QC results are OK) and from one visit to the next. This goes far beyond the responsibilities and qualifications of the technician. In France our guidelines state that the validation of the results is in two steps: analytical validation by the technician, biological validation by the pathologist. Check also in your national regulations and guidelines on path labs.

Regards
Ohlbe