Decree No. 463 / 2021 Coll.
Ordonnance on closer conditions for carrying out the clinical trial of medicinal products for human use
Valid
Order
Effective from 31.01.2022
463
DECLARATION
of 6 December 2021
on the closer conditions for carrying out the clinical trial of medicinal products for human use
The Ministry of Health shall determine, pursuant to § 114 (1) and for the implementation of § 53b (2) and § 56 (6) of Act No. 378 / 2007 Coll., on Medicines and on amendments to certain related laws (Act on Medicines), as amended by Act No. 66 / 2017 Coll.:
Clinical trial progress report
(1) A report on the course of the clinical trial is submitted
(a) in the case of a clinical trial where the first administration of an investigational medicinal product to a human is made, a clinical trial using investigational advanced therapy medicinal products and a clinical trial conducted on vulnerable subjects in accordance with the principles of good clinical practice over a period of 6 months, no later than 30 days from the date on which that period expires,
(b) for other clinical trials over a 12-month period, no later than 60 days from the date on which that period expires.
(2) The period for which the clinical trial course report is submitted starts to run from the date of the inclusion of the first subject in the clinical trial site. In justified cases, the Ethics Committee may request the submission of reports on the conduct of a clinical trial for a shorter period than that provided for in paragraph 1.
(3) The report on the conduct of the clinical trial contains the data set out in Annex 1 to this Regulation.
Monitoring requirements, content of basic documents and labelling of investigational medicinal products for low-intervention and cluster clinical trials carried out by non-commercial contracting entities
(1) Monitoring for low-intervention or cluster clinical trials carried out by non-commercial procuring entities which are not the basis for registration or modification of the marketing authorisation of a medicinal product may be provided by an employee of the health service provider or by another natural person who is not involved in the clinical trial. Monitoring for low-intervention or cluster studies during and at the end of the clinical trial shall include verifying that:
(a) each of the subjects of the trial has provided informed consent before their participation in the clinical trial;
(b) has a main examiner or examiner list of all persons involved in carrying out a clinical trial with the designation of the assigned clinical trial activity, powers and responsibilities;
(c) the data recorded in the evaluation body's record sheet are accurate, complete and verifiable according to the source documents;
(d) the main examiners and examiners comply with the current approved protocol and any amendments thereto; and
(e) derogations from the approved protocol and adverse reactions are recorded and reported.
(2) The requirements for the content of the basic clinical trial documents referred to in paragraph 1 are set out in Annex 2 to this Decree.
(3) For the clinical trials referred to in paragraph 1 where there is no blindness and where medicinal products and auxiliary medicinal products provided for in the approved protocol are used by medicinal products authorised in the Czech Republic, there is sufficient labelling in accordance with Section 37 of the Drug Act. If the marking of the investigational medicinal product is only within the scope of Section 37 of the Drug Act, the assessment of the batch of the medicinal product received by the subject shall be entered on the record sheet.
Repeal
They shall be deleted:
1. § 1 (2) (b) and (d), Part Three and Annexes 11 to 18 to Decree No. 226 / 2008 Coll., on good clinical practice and closer conditions of clinical trial of medicinal products, and
2. Decree No. 226 / 2008 Coll., on Good Clinical Practice and Closer Conditions of Clinical Evaluation of Medicinal Products.
Efficacy
This Decree shall take effect on 31 January 2022, with the exception of Article 3 (2), which shall take effect on 31 January 2025.
Minister for Health:
Mgr. et.
Příloha č. 1
Annex No 1 to Decree No 463 / 2021 Coll.
Content of data reported in the clinical trial course report
The clinical trial course report shall contain the following data:
(a) the name, European identification number and place of clinical trial;
(b) the period during which the report is drawn up;
(c) the date of inclusion of the first clinical trial subject, a brief description of the course of the clinical trial, changes in the clinical trial subjects, the number of subjects enrolled, those in the screening phase, the randomized subjects, and the number of subjects in the course of the treatment, those who have completed the treatment in accordance with the approved protocol and those who have completed the treatment prematurely, including an indication of the reason,
(d) a summary of any derogations from the approved protocol, a list of serious adverse events and information on any safety measures taken; and
(e) the date, first name, surname and signature of the person who drew up the report, if any.
Příloha č. 2
Annex No 2 to Decree No. 463 / 2021 Coll.
Requirements for basic documents for low-intervention or cluster clinical trials carried out by non-commercial procuring entities that will not be a basis for the marketing authorisation or amendment of a medicinal product
A. Content Lessons of the subject and written informed consent
The training of the evaluation body and the written informed consent shall include:
(a) an indication that the clinical trial is a research activity;
(b) the objectives of the clinical trial;
(c) for a randomized clinical trial, the likelihood of randomisation shall be reported;
(d) procedures and procedures in the course of a clinical trial which are of a research nature, including the indication of their risks to the subject;
(e) the definition of the responsibility of the evaluation body;
(f) a description of the course of treatment and the conditions of compensation to be provided to the subject in the event of damage to the health resulting from his participation in the clinical trial;
(g) the estimated costs of the subject and any compensation in connection with his participation in the clinical trial;
(h) information that the participation of the study subject in the clinical trial is voluntary and that the study subject may refuse or withdraw from participation in the clinical trial at any time, without prejudice to or loss of benefits to which he is otherwise entitled;
(i) information that auditors, monitors, ethics committees and the Institute have direct access to the original clinical documentation in order to verify the conduct of the clinical trial or data, without violating the confidentiality of information on the subjects of the evaluation, to the extent permitted by law, and that by signing the written informed consent, the subject or his legal representative agrees to this fact;
(j) information that the records under which the subject of the evaluation can be identified are kept confidential and will not, to the extent guaranteed by law, be made publicly available; if the results of the clinical trial are published, the identity of the subject will not be disclosed;
(k) information that the evaluation body or its legal representative will be informed in good time if there is any information that might be relevant to the decision of the evaluation body to continue to participate in the clinical trial;
(l) information on persons from whom it is possible to obtain further information on the clinical trial and the rights of the subjects and who to contact if harm is caused to their health in connection with the clinical trial,
(m) foreseeable circumstances and reasons for which the participation of the subject in the clinical trial may be terminated;
(n) the expected duration of participation of the subject in the clinical trial;
(o) the planned number of subjects to be included in the clinical trial.
B. Clinical trial protocol and addenda to the protocol
The clinical trial protocol shall include the following data. Clinical trial-specific information may be provided in separate annexes to the clinical trial protocol. Some of the information listed below may be contained in other documents, such as the Summary of Product Characteristics or the scientific text, with reference to those documents in the Protocol.
B. 1. General information
(a) Name of the clinical trial;
(b) the European Clinical Evaluation Identification Number;
(c) the identification details of the person of the contracting entity which refer to the name, registered office and identification number of the person, if any, if any, if it is a legal person, or the name, name, surname, date of birth and registered office,
(d) the protocol identification number, the date and the version number of the protocol. All additions must also be dated and marked with the version number.
B. 2. Basic information
(a) the name and description of the investigational medicinal product, distinguishing between the medicinal product tested, comparative or placebo;
(b) an overview of the known and potential risks and benefits to the evaluation bodies. If the inventory of known and potential risks and benefits does not differ from the SPC, reference may be made to the SPC,
(c) a statement that the clinical trial will be carried out in accordance with the protocol, legislation and good clinical practice;
(d) the definition of the population studied.
B. 3. Clinical trial plan
The clinical trial plan shall include in particular:
(a) scientific justification for carrying out the clinical trial;
(b) the specific indication of the primary and, where appropriate, secondary objectives to be pursued during the clinical trial;
(c) a description of the type of clinical trial to be conducted, such as double-blind, placebo-controlled or parallel arrangements, and a description of the procedures carried out;
(d) a description of the treatment during the clinical trial, dose and dosing schedule of the investigational medicinal product. Expected duration of participation of the subject in the clinical trial, description of the order and duration of all clinical trial time periods, including any follow-up,
(e) a description of the rules on termination and the criteria for interruption for individual subjects, part of the study and the whole study;
(f) procedures for the retention of clinical trial randomisation codes and procedures for unblinded codes;
(g) an indication of all data to be recorded in the records of the evaluation bodies. This information must also be recorded in the health file,
(h) selection and method of elimination of subjects, which includes criteria for the inclusion of subjects in a clinical trial, criteria for non-inclusion of subjects in a clinical trial and criteria for early termination of participation of subjects in a clinical trial;
(i) a list of authorised medicinal products, including auxiliary medicinal products, and prohibited medicinal products before and, where appropriate, during the clinical trial;
(j) procedures for monitoring compliance with treatment procedures and cooperation between evaluation bodies (compliance);
(k) description and definition of the assessed parameters;
(l) procedures for obtaining reports of adverse events and intercurrent diseases, including their recording and reporting. Definition of the safety reference information to be based on when assessing and reporting adverse reactions,
(m) the nature and duration of the follow-up of the evaluation subjects following an adverse event requiring further monitoring. Adverse events requiring further monitoring are listed in the clinical trial protocol.
B. 4. Statistics
(a) A brief description of the statistics and statistical methods to be used;
(b) justification for the size of the sample of the population monitored, including selection of assessment bodies to be included in the analysis of procedures for treatment of missing, unused and incorrect data.
B. 5.
(a) how to ensure direct access to source and other documentation for the purpose of carrying out the audit, the supervision of the Ethics Committee, inspection of inspection offices and, where appropriate, monitoring of the clinical trial;
(b) the method of ensuring the control and quality of the conduct of the clinical trial, with sufficient reference to the standard procedure;
(c) the manner in which data and records are handled, including their retention time;
(d) the method of financing and ensuring the insurance of the clinical trial.
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Regulation Information
| Citation | Decree No. 463 / 2021 Coll., on closer conditions for conducting a clinical trial of medicinal products for human use |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 10.12.2021 |
|---|---|
| Effective from | 31.01.2022 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
Public Contracts 5
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