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Thread: Can CRA/study monitor from a sponsor meet study subjects/patients?

  1. #1
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    Can CRA/study monitor from a sponsor meet study subjects/patients?

    A CRA from one of our sponsors asked that they would like to meet the patient to say hello. As site we have never had this request before. Can CRA meet our patients?

    your advice would be appreciated. Thank you.

  2. #2
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    Interesting that a very similar question was asked of RQA on their GCP Discussion Forum (www.theRQA.com). Is this the same person asking the question? You might find what was said by RQA useful or informative, of course it is just an opinion.
    You should read MHRA GCP Guide (2012). >>> Ask yourself these questions? Has the subject given explicit consent to such activity and has the EC approved of this? What does the risk assessment plan say? What does the monitoring plan say? >>>.Here are some first thoughts:- >>> Of course the subject has given consent to the monitor (sponsor's agent) to know their identity and see all details about them. This also means that the monitor can verify that the subjects are "genuine" and have attended the investigator site as documented. This may mean looking at visit logs and clinic diaries and/or questioning staff.. >>> Subjects do have a right to privacy as well as confidentiality. It may be assumed that the interaction between an investigator and their patient/subject is a private matter. Subjects have a right to expect that only those they have given permission to treat/examine them, are present during this clinical consultation.>>> It does depend upon which jurisdiction the study is in. In the UK MHRA GCP Guide (2012) does give guidance about getting the explicit consent of subjects to having their signed consent forms sent to the sponsor. In this case the sponsor's office personnel would now have access to personally identifiable information, but of course they must handle this information in accordance with data protection legislation (and the Ethics Committee must approve of this process). If subjects can explicitly consent to this (and if the Ethics Committee approves this) it would be logical that subjects could also explicitly consent to sponsor personnel being present during clinical trial consultations. >>> The big question is why is this required? If it is the situation that the trial involves such cutting edge technology, such that an expert from the sponsor needs, to not only train the investigator, but witness them performing the trial a few times? If this was a documented risk reduction process and approved by the subject and Ethics Committee, then it could be a useful addition to the trial. >>> Phase one clinics usually have healthy volunteers and often their consent forms explicitly allow sponsor's agents to be present during, for instance, the first dosing. Proper procedures should be adhered to so that the subjects privacy and confidentiality are not breached and all legal requirements are observed. >>> it would be interesting to hear from others particularly those working in Phase One.

  3. #3
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    Dear a123456,

    Thank you so much for your kind advice and very useful information. It was not me asking in RQA forum.

    I checked the study informed consent on the same day I posted my question; please see details below. Then I informed the CRA that patients consented for only their medical records to be reviewed by sponsor. The CRA was fine with this. I should have deleted my thread but I forgot. Sorry about this.

    “I understand that my medical records may be looked at by authorised individuals from the study team, sponsor or regulatory authorities in order to check that the study is being carried out correctly. I give permission for these bodies to have access to my medical records for the above study and any further research that may be conducted in relation to it.

    I give permission for members of the research team, the Sponsor and its representatives to have access to my anonymised results.
    I understand that my name will not be linked with the research materials, and I will not be identified or identifiable in the report or reports that result from the research.”

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