Questions regarding the new Act on Pharmaceuticals

  1. Question: What does the term “commencement of a clinical trial” mean – the initiation or the inclusion of the first patient? Is it necessary to report both? Is it necessary to report for each site separately?

    Answer: The commencement of a clinical trial means the moment when the first trial subject (or his/her legal representative) signs the Informed Consent Form (Decree No 226/2008 Coll. Section 1). This applies to the first site in the Czech Republic. This moment is to be reported.
  2. Question: The end of a clinical trial is reported to MEC and LEC, SÚKL wishes to have information on the end of trial. What information specifically is to be provided?

    Answer: In compliance with Section 56, paragraph (5) of Act No 378/2007 Coll. on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), the sponsor informs SÚKL as well as the concerned ethics committees on the end of the clinical trial. The sponsor submits to SÚKL the European form „CT End of Trial Form“ and information on the end of the trial containing data pursuant to Annex 8 to Decree No  226/2008 Coll., on good clinical practice and detailed conditions for the conduct of a clinical  trial. The European Form should be submitted after the end of the clinical trial in the Czech Republic, as well as after its global conclusion.
    Where an early termination of a clinical trial is concerned, the period for the submission of the information by the sponsor is reduced to 15 days  - Section 56 , paragraph 5 of Act No 378/2007 Coll. on Pharmaceuticals and on Amendments to Some Relate Acts (Act on Pharmaceuticals)
  3. Question: Is it possible to lodge the application for authorisation/notification of a clinical trial concurrently with SÚKL and with the EC or is a different procedure preferred?

    Answer: The assessment of the application for authorisation/notification of a clinical trial by SÚKL and by the EC  is independent. It is therefore possible and appropriate to submit the application to SÚKL and to the EC at the same time. It is important to submit the application to all ethics committees (i.e. to the multicentric ethics committee and to all local ECs) at one time.
  4. Question: If the Investigator's Brochure has not changed, is it necessary to inform SÚKL  to this effect? What is the potential penalty for failure to provide the information?

    Answer: At least an annual update of the Investigator's  Brochure (hereinafter referred to as “IB”) is mandatory by law (Act on Pharmaceuticals, Section 56,, paragraph 4 refers). Where no changes occur and no new information about the medicinal product is available, it is necessary to inform SÚKL  to this effect as well, i.e. instead of sending an updated version of the IB it is necessary to send a letter stating that no changes have occurred.   
  5. Question: How will validation be ensured if the sponsor upon second submission of the study refers to as much as 50% of previously submitted documentation?

    Answer: The sponsor has to include this information in the cover letter  together with a list of documentation which has been submitted previously and which they intend to use in this assessment procedure (to which they wish to refer). The original study has to be exactly identified (it is necessary to provide SÚKL ref. no. (“č.j.”) or file ID (“sp.zn.”)). Validation should not be adversely affected by this.
  6. Question: What about the payment of the 30 CZK fee for a visit to a doctor? Who will pay it in the scope of a clinical trial?

    Answer:
    a)       If it concerns a visit for the purposes of the clinical trial, it is paid by the sponsor and is not charged to the insurance company ; it is hence unnecessary to collect the 30 CZK.
    b)       If it concerns a visit both for the purposes of the clinical trial and for the purposes of a routine medical check up, which is charged to the insurance company, then it is necessary to collect the 30 CZK fee which should be covered from the sponsor's payment for the visit and not collected from the patient. This should be specified by the contract concluded by the healthcare facility and the sponsor.
  7. Question: Is it possible to use a “general” insurance policy or is it necessary to conclude a “special” insurance policy for each CT?

    Answer: Pursuant to the Act, the sponsor must be insured for the clinical trial, but it is not specified whether this should be done separately for each clinical trial. If the sponsor has a general insurance covering activities pertaining to the conduct of clinical trials, it is acceptable.

GCP Certificates:

  1. Question: Are GCP certificates granted by the sponsor to investigators after the Investigator's  Meeting sufficient?

    Answer: At the moment, these are acceptable for the relevant clinical trial.
  2. Question: Will the GCP Certificate include also a GLP section for CT?

    Answer: No, these are two different documents.

Published information about CT:

  1. Question: If  Patient Information is to be published how will their updating be catered for?

    Answer: In these cases, the updated version of the Patient Information will be published.
  2. Question: Will this “database” of information on clinical trials be “live”, i.e. will it be updated, or will data be entered at certain time intervals?

    Answer: Information on a clinical trial will be published after the issuance of approval by SÚKL and will be amended when other information  for publication become available (e.g. approval of the ethics committee for multicentric clinical trials, information on commencement, etc.).

Adverse reaction reporting:

Question: The word “forthwith” has been added to Section 58, paragraph (7) of the Act on Pharmaceuticals, in the requirement for informing all investigators on all SUSARs.

Answer: Guideline KLH-21 also stipulates that the investigator  should be “forthwith” notified of all SUSARs occurring within the territory of the Czech Republic, without identification of the trial subject and the investigational product. SUSARs outside the territory of the Czech Republic should be reported in 6-month intervals by means of Line listing.