Decree No. 301 / 2003 Coll.
Decree amending Decree No. 472 / 2000 Coll., establishing good clinical practice and closer conditions for clinical evaluation of medicinal products
Valid
Order
Effective from 01.10.2003
Text versions:
01.10.2003
18.09.2003
301
DECLARATION
of 3 September 2003
amending Decree No. 472 / 2000 Coll., laying down good clinical practice and detailed conditions for clinical trial of medicinal products
The Ministry of Health and the Ministry of Agriculture shall determine, pursuant to § 34 (6), § 34 (7) (d), § 35 (1) and (7), § 36 (1) and (7), § 38 (1) (a), § 38 (7) and § 75 (2) (b) of Act No. 79 / 1997 Coll., on medicinal products and on amendments and additions to certain related laws, as amended by Act No. 149 / 2000 Coll. and Act No. 129 / 2003 Coll. (hereinafter "the Act '):
Decree No. 472 / 2000 Coll., laying down good clinical practice and further conditions for clinical trial of medicinal products, is amended as follows:
1. in § 1 (1) (a), the words "(§ 33 (1) and (4) of the Act)" shall be replaced by "[§ 33 (3) (i) of the Law."
2. Paragraph 1 (1) shall be replaced by a semicolon at the end of the text in point (c) and supplemented by the words "if the clinical trial protocol provides for the conclusion of a clinical trial differently, the time set by the protocol shall be deemed to end the clinical trial."
3. in Article 1 (1), points (d), (e) and (h) are deleted;
Points (f) and (g) shall be renumbered (d) and (e) and points (i) to (n) shall be renumbered (f) to (k).
4. In Paragraph 2 (2), the part of the sentence first after the semicolon and the sentences second and third are deleted.
5. Paragraph 2 (5) is deleted.
6. Paragraph 3 (1) to (3) reads as follows:
"(1) The establishment of an Ethics Commission under Paragraph 35 (1) of the Act shall mean the written appointment of members of an Ethics Commission in such a way that their number is at least five and that the Ethics Commission has the qualifications and experience to assess and evaluate the submitted clinical trials from a scientific, medical and ethical point of view. Before the appointment of members of the Ethics Commission, the Health Facility, or the Ministry of Health or the Regional Office (hereinafter referred to as" the person '), which is established by the Ethics Commission, shall seek their written consent to membership of the Ethics Commission and compliance with the conditions set out in § 35 (1) (a) to (c) of the Act.
(2) The appointment of new members of the Commission after the commission has already been established shall be treated mutatis mutandis in accordance with paragraph 1.
(3) The person who has set up the Ethics Commission shall immediately notify the State Institute for Drug Control, including further information under Section 35 (3) of the Act. "
7. In Article 3, the following paragraph 4 is inserted after paragraph 3:
"(4) If the Ethics Committee is to carry out the activities of the Ethics Committee for Multi-Centre Evaluation, the Ministry of Health shall apply for this designation and shall at the same time provide the State Institute for Drug Control with a copy of the application together with the documentation provided for in the Ethics Committee's activities by law and by this decree. The State Institute for Drug Control shall verify that it fulfils the conditions laid down within 60 days and forward its opinion to the Ministry of Health. The Ministry of Health shall decide within 30 days of receipt of the opinion of the State Institute for Drug Control whether the Ethics Commission may be designated as the Ethics Committee for Multicentre Evaluation. This designation shall be notified by the Ministry of Health to the Ethics Commission, the person who established it and the State Institute for Drug Control. ';
Paragraph 4 shall become paragraph 5.
8. In Paragraph 4 (1), the following sentence is inserted after the second sentence: "At least five members of the Ethics Committee, among whom there is a non-medical education or professional scientific qualifications, and a non-employment, similar employment relationship or dependent status to the medical institution in which the proposed clinical trial will take place, are required for the adoption of an opinion."
9. In Article 4, at the end of paragraph 2, the dot is replaced by a comma and the following points (g) and (h) are added:
"(g) the definition of the manner and time limits by which the Ethics Commission communicates the data required by the law and by this decree to the examiner or contracting authority, the State Institute for Drug Control and, in the case of the Ethics Committee, also to the Ethics Committees where they are established at the evaluation sites,
(h) working procedures under specific legislation; (2a) where the Ethics Committee issues its opinions for other fields of biomedical research than for clinical evaluation of medicinal products;
2a) For example, Act No. 123 / 2000 Coll., on Medical Devices and on the Amendment of Certain Related Acts, as amended by Act No. 130 / 2003 Coll. '
10. in Article 4 (3), "Article 34 (6)" is replaced by "Article 35 (12)";
11. in Article 4, the following paragraph 6 is added:
"(6) The death of the Ethics Commission shall be notified without delay to the State Institute for Drug Control by the person who set up the Ethics Commission. This person shall at the same time notify the State Institute for Drug Control whether another commission is taking over the activities of the extinct Ethics Commission, shall also communicate the list of ongoing clinical trials supervised by the deceased Committee and how the retention or transmission of documentation to the extinct Ethics Commission is ensured. ';
12. in Article 5 (2) (e):
"(e) detailed information on compensation for expenditure and remuneration for evaluation bodies;"
13. in Article 5 (2), the following point (g) is inserted after point (f):
"(g) insurance contract for the insurance of the evaluation body, the investigator and the contracting entity pursuant to § 34 (3) (f) of the Act,"
Point (g) shall be renumbered as point (h).
14. in Article 5 (3) to (6):
"(3) When assessing compensation, insurance and remuneration, the Ethics Committee always assesses whether:
(a) compensation or insurance of the subject of the evaluation in the event of death or damage to health as a result of a clinical trial shall be provided by an insurance contract, which shall be submitted by the contracting authority together with the application;
(b) the insurance of liability for the investigator and the contracting entity shall be provided by an insurance contract submitted by the contracting entity together with the application or, where appropriate, by the insurance of liability of the investigator or contracting entity not forming part of their employment relationships;
(c) the compensation does not exceed the costs evidently incurred by the entity or by the investigator in connection with its participation in the clinical trial, and also whether the fee for the examiner is known and fixed in advance, and whether the contracting authority has submitted a written agreement with the examiner, together with the application, on the amount of that remuneration;
(d) the level of remuneration for the subjects is consistent with the nature of the clinical trial, in particular in relation to those research activities from which the subject does not benefit directly.
(4) In the case of clinical trials where it is not possible to obtain its consent before the entity is included in the clinical trial, the Ethics Panel shall assess how and within what time limits the protocol provides for the request of the consent of the legal representative of the evaluation body or of the entity itself, and shall consider whether it is not appropriate to make the inclusion of each individual subject subject subject subject subject subject subject subject subject subject subject subject subject subject subject subject subject subject subject subject subject subject subject subject subject subject subject subject to its consent conditional.
(5) The Ethics Commission will provide its opinion to the contracting authority and the State Institute for Drug Control within the time limit laid down in Sections 35 (8) and (10) of the Act.
(6) Where a multi-centre clinical trial is concerned, the Ethics Committee for Multi-Centre Evaluation shall forward its opinion to the Ethics Committees for the individual clinical trial sites mentioned in the application, the contracting authority and the State Institute for Drug Control within the time limit laid down in Section 36 (2) of the Act. The Ethics Panel for individual clinical trial sites shall also give its opinion to the contracting entity, the relevant Ethics Committee for multi-centre evaluations and the State Institute for Drug Control in accordance with Section 36 (3) of the Act. ';
Paragraph 6 shall become paragraph 7.
15. in Article 5 (7), the words "the date of receipt of the application and the list of clinical trial sites on which the Ethics Committee has expressed its views and overseen," shall be added at the end of point (a).
16. In Article 5, at the end of paragraph 7, the dot is replaced by a comma and the following points (e) and (f) are added:
"(e) in cases of clinical trials where it is not possible to obtain its consent before the entity is included in the clinical trial, the Ethics Committee shall expressly state whether it agrees to the procedure for the inclusion of the subjects of the evaluation referred to in the Protocol and shall indicate whether it makes the inclusion of each individual subject subject subject subject to its agreement; where the classification of each individual body makes the evaluation conditional on its agreement, it shall also indicate the manner in which the examiner requests such consent and how the Ethics Committee will provide the relevant observations without delay;
(f) where the opinion is delivered by the Ethics Panel on Multi-Centre Evaluation, this shall be given, together with a list of the clinical trial sites on which it has expressed its views and over which it has supervised. ";
17.
Changes in clinical trial conditions
(1) The notification of amendments to the Protocol pursuant to Article 38 (1) (a) of the Act shall be made in writing with the justification and proposal of the revised relevant part of the dossier to which the Appendix applies. Where there is an amendment to a protocol of an administrative or organisational nature or consisting of a change in the data necessary to ensure synergies (e.g. telephone, fax, e-mail address) of ethical commissions and the State Institute for Drug Control with the contracting authority, the contracting authority shall immediately inform the State Institute for Drug Control and the Ethics Commission which have expressed their opinion on the clinical evaluation. Such an amendment shall not be considered as a significant amendment to the Protocol.
(2) The Ethics Committee shall act mutatis mutandis in assessing the Appendix to the Protocol and issuing an opinion on it in accordance with Article 5.
(3) The withdrawal of the opinion of the Ethics Commission (Section 36 (7) of the Act) shall be notified without delay by the Ethics Committee to the investigator, the sponsor and the State Institute for Drug Control. Except where the safety of the subjects of the evaluation is compromised, the Ethics Committee shall seek the opinion of the contracting authority or, where appropriate, the examiner before taking a decision. The Ethics Committee on Multicentre Evaluation will also seek opinions from Ethics Committees at individual evaluation sites before deciding.
(4) Withdrawal of the Ethics Commission's consent contains:
(a) the identification details of the clinical trial, in particular the name of the clinical trial, the indication of the contracting entity and the places of the evaluation for which the consent is withdrawn, and, where appropriate, the protocol identification number;
(b) justification for the withdrawal of consent;
(c) measures to end the clinical trial, in particular the transfer of the patient to another treatment, where consent has been withdrawn due to a threat to the safety of the subjects of the trial and is not already included in the protocol;
(d) the date on which the consent was withdrawn and the signature of at least one member of the commission authorised to do so by written procedure of the Ethics Committee. ';
18. In Article 7, the following paragraph 2 is inserted after paragraph 1:
"(2) The investigator shall obtain the written informed consent of the subject or his legal representative before each subject is included in the study; in the case of clinical trials where such approval cannot be obtained before the entity is included in the clinical trial, the procedure laid down in Article 34 (8) of the Act and Article 5 (4) of this Decree shall be followed. ';
Paragraphs 2 to 5 shall be renumbered paragraphs 3 to 6.
19. in Paragraph 8 (3), the sentences of the second and third shall be deleted;
20. In Article 8, the following paragraph 5 is added:
"(5) In the case of clinical trials in minors
(a) the examiner shall obtain informed consent under Article 34 (6) of the Act;
(b) the examiner or person authorised by him who has experience in the work of children shall provide the minor, within the scope of his or her intended capacity to understand, with true information about the clinical trial, in particular its risks and benefits, possible discomfort and potential difficulties, as well as the right to withdraw from the clinical trial at any time;
(c) where the capacity of a minor so permits, the examiner or the person authorised by him shall provide him with written information on the clinical trial to the extent appropriate to his or her degree of development and shall respect his or her wish to participate in the clinical trial;
(d) the Ethics Committee shall supervise at least half-yearly intervals; where the Ethics Committee does not have experience in the field of paediatric medicine, it shall ensure the participation of an expert qualified in the field of pediatric medicine for supervision. ';
21. Paragraph 9 (6) reads:
"(6) The report on the course of the clinical trial (Paragraph 38 (10) of the Act) contains the information set out in Annex 4."
22. in Paragraph 9 (8), including footnotes (3a) and (3b):
"(8) The clinical trial documentation shall be kept by the investigator in such a way as to ensure the protection of data on the subject's person under specific legislation. (3a) Upon completion of the clinical trial, the investigator shall ensure that the source documents are kept in accordance with the provisions governing the retention of medical documents3b) and with specific legislation; (3a) the assessment bodies' identification codes shall be kept for at least 15 years.
3a) Act No. 101 / 2000 Coll., on the protection of personal data and on the amendment of certain laws, as amended.
3b) § 67b of Act No. 20 / 1966 Coll., on the Care of People's Health, as amended. Act No. 97 / 1974 Coll., on archiving, as amended. '
23. In the first sentence of Paragraph 10 (1), the words "the competent Ethics Commission and the contracting entities under Section 38 (3) (c) of the Act 'are replaced by the words" the contracting entities under Section 38b (1) of the Act'.
24. Paragraph 10 (3) is deleted.
25. in Article 11 (2) (a), the words "the relevant medical institution, the contracting authority and the relevant ethics committee" shall be replaced by the words "the State Institute for the Control of Medicines, the contracting authority and the Ethics Commission, or the Ethics Commission, as the case may be, which have expressed their views on the clinical evaluation in question," and the words "or the Ethics Committees which have expressed their views on the clinical evaluation shall be inserted after the words" the Ethics Commission. "
26. in Article 11 (2) (b), the words "the relevant medical institution and the relevant Ethics Commission" shall be replaced by the words "the Ethics Commission or, where appropriate, the Ethics Committee, which expressed their views on the clinical evaluation."
27th Paragraph 11 (4) reads:
"(4) The examiner shall inform the contracting authority and the Ethics Commission or, where appropriate, the Ethics Committee which have expressed their views on the clinical trial concerned of the early termination of the clinical trial at the site concerned, except in the cases referred to in paragraphs 2 and 3. ';
28. In Article 12, the sentence "The contracting authority shall designate the examiner, taking into account his qualifications, the nature of the clinical trial and the equipment of the medical establishment in which the clinical trial is to be carried out," is inserted at the beginning of paragraph 2.
29. in Article 12 (4) (a), the words "subject to the condition of Article 38 (3) (f) of the Act," shall be deleted;
30. In Paragraph 12, the dot is replaced by a comma at the end of paragraph 12 and the following point (e) is added:
"(e) a request for the opinion of the Ethics Commission shall be submitted to a single Ethics Committee for multi-centre evaluations.";
31. in Paragraph 13 (1):
"(1) The application for authorisation of a clinical trial or for notification of a clinical trial (Section 37 (2) of the Act) shall be submitted by the contracting authority or by a person authorised by it to the State Institute for Drug Control. Where an application or notification is made by a person other than the contracting entity, it shall be submitted with each application or notification of the mandate of the contracting entity to that person. Individual parts of the documentation shall be presented separately, with continuously numbered pages, indicating the content. The application shall be accompanied by proof of reimbursement of the costs of the examination of the application or of the declaration. ';
32. in Paragraph 13 (2) (a), the words "[Paragraph 38 (2) (a) of the Law]" shall be deleted;
33. in Article 13 (2) (b), the words "(Article 2 (13) of the Law)" shall be deleted;
34. In Article 13, at the end of paragraph 2, the dot is replaced by a comma and the following point (h) is added:
"(h) in the case of a multi-centre clinical trial, information on which ethics committee for multi-centre evaluations has been submitted for an opinion."
35. in Paragraph 13 (4), the words "[Paragraph 9 (1) (a) (1) (1) of the Act]" shall be deleted;
36. In Article 14 (6), the words "for the same period as the examiner [Paragraph 38 (3) (f) of the Act] 'are deleted.
37. in Paragraph 15 (1), the words "and the Ethical Commission for Multicentre Evaluation, if such a panel has expressed its opinion on the clinical trial," shall be inserted after the words "State Institute for Drug Control."
38. in Paragraph 15 (2):
"(2) The investigator shall inform the Ethics Committee, which has given an opinion and supervised the clinical trial at the site. '
39. Paragraph 15 (3) is deleted.
Paragraph 4 shall become paragraph 3.
40. In Paragraph 15 (3), the words "[Paragraph 38 (2) (b) (6) of the Act]" shall be deleted.
41.Paragraph 16 (1) reads as follows:
"(1) The amendments to the clinical trial conditions reported to the State Institute for Drug Control and the Ethics Committees which have expressed their opinion on the clinical trial shall be considered as amendments to the protocol consisting in particular of substantial changes in the planned number of subjects, the dosage and duration of administration of the investigational medicinal products, changes in the entry and exit conditions, evaluated parameters or sampling procedures. The notification of a change to the conditions of the clinical trial shall be accompanied by proof that the cost has been paid for the examination of the application. ';
42. Paragraph 16 (2) is deleted.
Paragraph 3 shall become paragraph 2.
43. In Section 17, the words "and the Ethics Commission, which have expressed their opinion on the clinical trial," shall be inserted after the words "State Institute for Drug Control."
44. in Paragraph 18 (1):
"(1) Information on the termination of a clinical trial in the Czech Republic pursuant to § 38 (5) of the Act contains the information set out in Annex 7."
45. in Paragraph 18 (2), the words "[Paragraph 38 (2) (b) (7) of the Law]" shall be deleted;
46. In Article 19 (2), the words "[Paragraph 38 (2) (c) of the Act] 'are deleted.
47. in Paragraph 22 (2), the words "[Paragraph 12 (1) (a) (1) (1) of the Act]" shall be deleted;
48. in § 28 (2) (c), the words "(§ 2 (13) of the Act)" shall be deleted;
49. in Paragraph 28 (2) (h), the words "under Paragraph 38 (2) (b) (6) of the Act" shall be deleted.
50. In Article 28 (3), the words "[Paragraph 12 (1) (a) (1) (1) of the Act] 'are deleted.
This Decree shall take effect on 1 October 2003.
Minister:
Dr. Součková v. r.
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Regulation Information
| Citation | Decree No. 301 / 2003 Coll., amending Decree No. 472 / 2000 Coll., laying down good clinical practice and closer conditions for clinical evaluation of medicinal products |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 18.09.2003 |
|---|---|
| Effective from | 01.10.2003 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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