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Thread: ‘Re-consenting’ trial participants

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  1. #1
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    ‘Re-consenting’ trial participants

    Hi all,
    I’ve been searching for some time now (without success) for information regarding whether trial participants need to provide additional consent/re-consent in certain situations. Examples of such situations include:

    - a substantial amendment to the protocol is implemented that involves an additional visit/assessment/procedure

    - a participant consent to take part in a trial but is found to be ineligible at screening due a transient/reversible condition. E.g. the subject meets all other criteria but is showing early signs of a common cold infection (that will likely fully resolve within a few weeks); another example is where an inclusion criterion is a flare-up of a dermatological condition (e.g. eczema) that must be above a minimum severity score – a patient’s condition may not be sufficiently severe at one screening visit but in the subsequent weeks/months increases in severity above the minimum threshold. Should/can this participant be contacted to attend a second screening visit at a later date, and if so, should additional consent be sought given that no aspect of the trial (and therefore what the participant is consenting to) has changed since the first screening visit?

    If anyone has come across such guidance/information elsewhere I’d be very grateful if you could point me in the right direction!

    Many thanks

  2. #2
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    Re-consenting Trial Participants

    Concerning re-screening, the approved protocol should state the criteria for re-screening, considering safety/ethical implications as well as any impact to the data integrity and statistical analysis. Many measures cannot just be repeated without adversely effecting the outcomes data. Often there may be a need to use alternative forms of certain scales and there may need to be a defined waiting period between screening and re-screening. In other circumstances re-screening may not be allowed at all. The approved protocol should give clear guidance about the procedure for re-screening, including tests that need to be repeated, if the subject needs to be considered a screen failure to be re-screened and any timelines that need to be considered. Data management procedures should also be defined in the appropriate site instruction materials according to approved practices.

    In regards to re-consenting, ICDs must be signed prior to any study activities being conducted . Informed consent should be viewed as a process, rather than a single event;. Informed consent as a process includes maintaining the subject's consent during the entire study The site staff should also be aware that once the ICD is signed any observed or reported SAE must be reported …”
    We are obliged by ICH GCP 4.8.2, to inform ongoing subjects in a timely manner, if new information becomes available that may be relevant and might impact their wish to remain in the study. Changes in the number or nature of visits would definitely impact the subjects willingness to continue in the trial ad therefore the subject should agree to this through a consent form.

  3. #3
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    Hello,

    We have an instance in which a subject has entered (screened and randomized) a PK clinical study.
    Due to a technical problem a delay of collecting blood occurred and the patient was withdrawn from the study.

    The patient wanted to re enter the study and the doctor did not see any safety problems to re-enter the study. After waiting over 30 days ( one of the exclusion criteria's is that no IMP should be given before 30 days) and after all inclusion criteria and all exclusion criteria were fulfilled during re-screening and the patient was allowed to enter the study.

    There was no particular explanation of re-screening of patients in the protocol.

    We are wondering.

    1) We believe this patient was entered as according to the protocol. Would you say that this is true, or not?

    2) If one would consider that this patient was entered not according to the protocol, as the investigator did not follow the protocol, and as such a "deviation" , what classification would the deviation be considered? A "comment", A "minor, A "major", or A "critical" deviation/observation.

    3) For a clinical study to be considered not to be in compliance to GCP what level of a deviation or multiple deviations would need to occur i.e. 1 critical observation, 5 major observations=critical (non complaint) etc.. etc..

    4) Does re-screening and re-entering need to be specified in the protocol?

    We have looked for guidance documentation in regards to GCP EMA/FDA/ICH and have not found any to help us for these items and appreciated if you know of any for any/all answers.

  4. #4
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    A protocol mandated test not done, lead to subject withdrawal. This means that data may not be usable for certain purposes. Obviously needs documented examination of the safety/well being and data integrity implications of such a lack of protocol compliance. Ideally the protocol should also cover what procedures are followed when a test is not done (including any remedial actions to ensure subject well being). CAPA to prevent recurrence at that site and throughout the trial at all centres. Interestingly FDA Warning Letters often cite "tests not done" as a significant problem.
    If not in the protocol, then there should be a documented Process for re-screening and re-entry (see previous forum responses) and for tests not done. Your new process could be a trial specific process or a process for all trials (SOP, etc). Part of your CAPA could be to make sure that the protocol template and the SOPs are updated to include provision for these problems (re-consent and tests not done). The CAPA should cover whether the trial site(s) may also need to update their documented processes to make sure tests are done (why was this test not done), how to prevent recurrence in other subjects/trials ; and what do to when tests are not done.

    These incidents should be include in your escalation process, so that this event is examined in case it is a potential Serious Breach of GCP or the protocol. You need to document this decision. Check whether there are any local requirements to inform the Ethics Committee, oversight committees, management or Regulators.

    The Research Quality Association (www.theRQA.com) has a Q & As on screening and consent. The MHRA GCP Guide (2012) has a lots of information on screening; compliance; consent; etc.

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