Verbal medical history

Anon
17/07/2014 14:20

Is verbal medical history ever really enough?

GCP Committee
17/07/2014 14:39

As always it depends. For instance the approved protocol may require evidence of certain medical history parameters or it might state that the interview with the subject was enough. It might also be good to think of this problem in advance and relate it to a risk based approach. So, for a marketed IMP, which is being used very similarly to the label and not involving innovative trial design or measures, there may be no need to verify the verbal history unless it was of vital safety importance. >>> The MHRA GCP Guide (2012) [See the RQA webcast on the MHRA Guide for details] :- “subjects recruited via general advertisements and the investigator is not the primary care provider, past medical history will need to be obtained from the subject and the record of this may be the only source document available for the eligibility assessment. However, this could be subsequently verified by other means: for example, by the subject’s GP”. 11.5 Study documentation However for Phase I it states:- "Ideally .., the unit should make every effort to verify their medical history ...... This could include for example, questioning the subject about their own and relevant family medical history and contacting the GP.... For FIH trials, part of the MHRA scheme, must have a robust and formalised procedure ...”12.12. 5 [N.B. “must” has no reference] >> Also look at the RQA GCP Q & As. There is one on use of historic data and some on subject recruitment. >>> It would be interesting to hear from others.

Anon
02/12/2020 13:31

Not wanting to add a new chain unnecessarily but should the confirmation about the medical history be provided only by the GP? We've encountered some instances where the medical history is provided from the GP surgery but it isn't signed. This doesn't affect the eligibility assessment as that is done by the PI but in terms of verification of the medical history, must it only be the GP (signed) who can provide this or is it acceptable to receive an unsigned medical history from the GP's surgery?

Colin Wilsher
03/12/2020 11:26

I'd document a trial specific risk based approach such that you would determine what was required for high risk information (medical history data that was vital to enrolment, safety, wellbeing, privacy, rights or might jeopardise the quality and integrity of the data and judgements made upon the data and future data based upon this data); and what would be sufficient for low risk data (background medical history unlikely to influence enrolment, well being, privacy, rights and quality of data).

Anon
03/12/2020 11:59

Thank you.

Dominique Chesnais
15/12/2020 13:38

I agree with the information provided by the GCP Committee, as stated in the MHRA GCP Guide (2012). The subject’s verbal medical history could also be completed by getting and corroborating information with their current / recent drug prescriptions, their laboratory tests and other diagnostic assessments that they might personally possess. It is important to verify the subject’s verbal medical history and related information with their GP or specialist. With the medical facts collated by the investigator, s/he can forward a letter formalizing the subject’s medical history and their current therapy in order for the GP / specialist to confirm its correctness and its completeness. A printout of the subject’s essential medical information could be returned by the GP/specialist, when feasible and if acceptable. A critical point remains the validity of few specific inclusion and exclusion criteria that only a confirmed and detailed medical history can assert. It should be highlighted by the medical advisor/director of the trial which criteria must be established beyond the subject’s verbal medical history through a specific request of confirmation of these criteria with the GP/specialist. A specific disease, its evolution, its severity, its specific treatment can only be ascertained by the GP/specialist.

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