Good Clinical Practice Guide
Results 1 to 7 of 7

Thread: Research samples

  1. #1
    Forum Member
    Join Date
    Jan 2015
    Posts
    7

    Research samples

    Hi all,

    for samples collected in a clinical trial to be used for exploratory endpoints purposes (for example gene expression differences), are these also subject to the same regulations for clinical samples used to assess clinical endpoints or safety? Do the lab staff also need to have GCP training? Is it possible that these labs get inspected?

    Thanks.
    E

  2. #2
    i think you can check it in the best online sources...i have just finished my clinical research..

  3. #3
    Quote Originally Posted by amanda07 View Post
    i think you can check it in the best online sources...i have just finished my clinical research..
    it's good, thank you about info

  4. #4
    "Do the lab staff also need to have GCP training? Is it possible that these labs get inspected?" - What training is needed and how it is documented depends to some degree on the nature of the study. Some protocols need extensive training and others may need minimal, also dependent upon the background and experience of study staff. The regulations require that sponsors choose investigators qualified by training and experience. The regulations also require that investigators commit themselves to personally conduct or supervise the investigation.

  5. #5
    Forum Member
    Join Date
    Sep 2016
    Posts
    6

    Lightbulb Yes - GCP training is recommended and periodic refresh.

    Quote Originally Posted by Essaywriters View Post
    "Do the lab staff also need to have GCP training? Is it possible that these labs get inspected?" - What training is needed and how it is documented depends to some degree on the nature of the study. Some protocols need extensive training and others may need minimal, also dependent upon the background and experience of study staff. The regulations require that sponsors choose investigators qualified by training and experience. The regulations also require that investigators commit themselves to personally conduct or supervise the investigation.
    EMA Guidance : Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples

    All staff involved in the analysis or evaluation of clinical trial samples should receive GCP training commensurate with their roles and responsibilities.
    It is appropriate for laboratory staff to receive periodic GCP refresher training. Such training is especially important following changes to regulations and associated guidance documents.

  6. #6
    Forum Member
    Join Date
    Nov 2011
    Posts
    113
    A risk proportionate approach to GCP training might say that, for clinical samples which are not involved in safety or efficacy parameters and which are fully anonymised, GCP training would only need to cover the data quality and data integrity aspects.

  7. #7
    As far as I know:
    What training is needed and how it is documented depends to some degree on the nature of the study. Some protocols need extensive training and others may need minimal, also dependent upon the background and experience of study staff.


    The regulations require that sponsors choose investigators qualified by training and experience. FDA's guidance on Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects states that, "The investigator should ensure that any individual to whom a task is delegated is qualified by education, training, and experience (and state licensure where relevant) to perform the delegated task." Please remember while the clinical investigator can delegate tasks, he/she is ultimately the one responsible for overseeing the study and protecting the subjects from harm.


    The expectation is that investigators and sub-investigators and study staff will be knowledgeable about good clinical practice, including human subject protection, data integrity, recordkeeping, etc. Note that sponsors have discretion in determining what qualifications will be needed to conduct a study and may identify in the protocol a required frequency of GCP training and well as documentation of training, in which case the investigator and sub-investigators and study staff would be expected to meet that frequency of training in order to comply with the sponsors requirements.


    Documentation that demonstrates what training any member of the study staff has participated in is useful to maintain as part of the relevant study files.


    You may wish to consult the sponsor of your study to see if they agree that training of staff is acceptable.

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •