USA specific
1. How Do I Register Clinical Trials with The FDA?
2. When must a FDA 1572 form be updated?
There are two instances when it is necessary for an investigator to complete and sign a new 1572: when an investigator is participating in a new protocol that has been added to the IND and when a new investigator is added to the study (21 CFR 312.53(c)).
If there are other changes to information contained on a signed and dated 1572 (e.g., an IRB address change, the addition of new subinvestigators, the addition of a clinical research lab), the investigator should document the changes in the clinical study records and inform the sponsor of these changes, so that the sponsor can appropriately update the IND. The 1572 itself does not need to be revised and a new 1572 need not be completed and signed by the investigator. The sponsor can accumulate certain changes and submit this information to the IND in, for example, an information amendment or a protocol amendment. (source:
FDA.gov)
3. Who must be listed on the FD1572 as a Subinvestigator and what activities must the Investigator do to meet his/her obligations on the FD1572?
In general, Subinvestigators and Investigators are decision-makers for the study. If a medical professional has the appropriate credentials and the responsibility to decide 1) which subjects go on the study, 2) which subjects are removed from the study, 3) if investigational product should be stopped, reduced or increased separately from directions listed in the protocol, and/or 4) evaluate efficacy or safety results for the study subject, he/she should be listed as the Investigator or Subinvestigator on the FDA1572
EU specific
1. How Do I Register Clinical Trials with The EMA (European Medicines Agency)?
First you need to apply for a EudraCT number, which is a number to uniquely identify your study in all EMA regulated countries. This is done here:
https://eudract.ema.europa.eu/eudract/index.do. Subsequently, you must fill out the Clinical Trial Application (CTA) the same place. Please refer to the
EucraCT manual. The CTA is then submitted to the regulatory authorities in the specific countries. Unfortunately, the guidelines for submitting to different EMA countries is not standardized (yet).
2. What are the labelling requirements for clinical trial supplies?
Investigational medicinal products (IMPs) are required to be labelled for use in clinical trials. The labelling requirements are provided in
Annex 13 of Volume 4 of The Rules Governing Medicinal Products in the EU: Good Manufacturing Practices. Regulation 46 (external link) of
The Medicines for Human Use (Clinical Trial) Regulations 2004 (external link) allows for a particular situation where specific trial labelling is not required. This applies to trials of marketed products being used in certain situations.
A sample of the labelling is required as part of the clinical trial authorisation (CTA) application. This sample should include the text of the labelling to be used and be provided in a format representative in terms of size of the label to be used. Samples of the actual labels to be used may be provided but are not required. Where actual samples are not included, it will be assumed that the labelling is black type on a white background unless otherwise specified.
Where labelling is not included as part of the CTA application or where the labelling to be used does not contain all the items required by Annex 13, this should be justified.
3. Why is only one drug product named on the Clinical Trial Authorisation approval letter for trials involving more than one investigational medicinal product?
The structure of the CTA approval letter is such that only one product can be named. Since the CTA is approved for a protocol and not for individual products, the CTA approval letter covers all IMPs listed in the application form even although only one is named on the letter. The product which appears first in Section D of the application form is the product which will be named.
4. Where can I find contact information for the Competent Authorities in Europe?
5. Which of the Ethical Committees and Competent Authorities assesses which parts of the Clinical Trial Application (CTA) in the EMA member states?
6. What are the requirements for the legal representative of a non EU/EEA-sponsor in view of Article 19 of Directive 2001/20/EC?
If the sponsor is not established in the Community a legal representative of the sponsor has to be established in the Community (source:
eur-lex.europa.eu)7. Can a sponsor established in a third country open a subsidiary or branch in a EMA Member State to comply with the requirement of Directive 2001/20/EC that the sponsor or a legal representative of the sponsor must be established in the EU?
Yes.
Article 19 of Directive 2001/20/EC requires that the sponsor or a legal representative of the sponsor is established in the EU.
This does not exclude the possibility that this establishment is a branch or subsidiary of a legal person having its principal seat outside the EU. This establishment could be the sponsor or act as legal representative of the sponsor established outside the EU. (source:
ec.europa.eu)
