How to start

How to start

Starting to gather documents and references

thinking about what we need to know in our everyday activity

For the answers, we need an exact source (law + article, regulation, directive, …). Note: If the answer to the question is simply “no” and there is no text on the subject, no reference/source is required.

The answers should not exceed the “usual applications” we need for our needs. This is vague, but the goal of this database is not to write all articles into it. The most important things are:

• what are the relevant parts to have a look at
• what are the key points
• and is there a “known” (or better: a discrete!) exception which can take a foreign actor by surprise if not known.

Make sure to assign as best as possible whether it is for Human Medicine, MD (Medical Devices) studies, Non-Interventional Studies,…

For the general structure, please refer to the Table of Content: this is shape as a course, and we aim to answer all questions that a person could ask themselves. In doubt about where to put an information, look at where similar texts have been sorted!

Basic questions for the the GxPlex process of entries

1. Legal framework :
   • What laws are relevant to clinical studies?
     • IMP + Medical Devices
   • How is the regulatory framework organized in this country? (Law, decrees, jurisprudence…)
2. Delimitations of Clinical Trials#
   • What are the different kind of trials defined in the law?
3. Ethics Committee/Competent Authority submissions :
   • What is the process for submitting a clinical trial?
     • To whom and what is to be submitted?
       • Laws/rules?
4. Clinical Trial actors and personnel:
   • Who is defined and what are their roles?
5. Study Agreement/contract
   • Which laws apply to a study contract?
6. Informed Consent
   • Which laws apply to Informed Consent
     • Special needs and vulnerable subjects?
   • Data processing
     • Which laws apply to Consent to Data Processing
   • Bonus question: are PIs/SIs the only one allowed to perform an informed consent interview, according to the law or practice?
7. Recruitment strategies and material
   • Which laws apply to recruitment of subjects? (material + strategies)
8. Unblinding of subjects
   • Which laws apply to unblinding of subjects?
9. Electronic signatures
   • Which laws apply to electronic signatures?
10. Remote Source Data Verification
    • Laws and allowed practice?
11. Inspections :
    • Who can carry out inspections?
      • Local and/or foreign Competent Authorities?
      • Other administrations?
    • Which law defines who is the CA, and its tasks?
    • Are there any particularities to be noted?
12. AEs/SAEs/SUSARs:
    • What needs to be reported, and how?
      • How fast, by whom and to whom?
      • Difference IMP and Devices?
    • Is there a yearly DSUR to report, and to whom?
13. Corrective measures
    • In case of issues with the trial, how are corrective measures implemented by the Competent Authority/EC?
14. Archives :
    • What are the relevant national laws for archiving in the context of clinical trials?
      • Patient files?
      • Notable exceptions?
      • ...
15. Requirements for end, premature termination or halt of a trial
    • And legal definitions?
16. Annual submission/notification
    • Are there any annual submissions/notifications to be made (IMP + Device)
    • By the sponsor or by the investigator?
17. Final report
    • What are the requirements?
18. Is there and what is the standard for training/education in the GxP field?

Then what?

Then create an account, create and fill out a Document page (if it does not exist already) and start creating the References with the individual entries!

Make sure to give all information to tag the entry: a short summary, a list of Keywords (from the available list), Table of content/Module number,...

See you on Contribute to GxPlex for more information!

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