Decree of the Ministry of Health and the Ministry of Agriculture No. 472 / 2000 Coll.

Q: Is Decree of the Ministry of Health and the Ministry of Agriculture No. 472 / 2000 Coll. still valid?

Yes, Decree of the Ministry of Health and the Ministry of Agriculture No. 472 / 2000 Coll. is still valid and effective.

472

DECLARATION

Ministry of Health and Ministry of Agriculture

of 8 December 2000

laying down good clinical practice and detailed conditions for the clinical trial of medicinal products

The Ministry of Health and the Ministry of Agriculture provides, pursuant to § 75 (2) (b) of Act No. 79 / 1997 Coll., on Medicines and on amendments and additions to certain related laws, as amended by Act No. 149 / 2000 Coll., hereinafter referred to as "the Act ':

ČÁST PRVNÍ

Common provisions

§ 1

Preliminary provisions

(1) For the purposes of this decree:

(a) the commencement of the clinical trial of medicinal products for human use at the moment at which the first subject of the study [§ 33 (3) (i) of the Act] or his legal representative signs an informed consent to participate in the clinical trial in the Czech Republic;

(b) commencing the clinical trial of veterinary medicinal products at the moment when the clinical trial was authorised by the Institute for State Control of Veterinary Bioprafts and Medicines;

(c) the termination of the clinical trial of the medicinal product at the moment when, in relation to the subjects of the trial, the last act of the clinical trial protocol is performed in the Czech Republic; However, follow-up of the evaluation body shall not be considered as such; if the clinical trial protocol provides for the termination of the clinical trial differently, the time set by the protocol shall be deemed to be the end of the clinical trial;

(d) residues of all active substances or their metabolites remaining in the meat or other animal products to which the evaluated veterinary medicinal product has been administered;

(e) records of the evaluation bodies of documents in written, visual or electronic form intended to record all information which, under the clinical trial protocol, is transmitted by the sponsor to each evaluation body;

(f) by a contractual research organisation, a natural or legal person in a contractual relationship with a contracting entity which ensures that one or more of the activities or functions of the contracting entity relating to the clinical trial are carried out;

(g) quality assurance of all planned and systematic procedures to ensure that clinical trials are carried out and clinical trial data are obtained, recorded and reported in accordance with good clinical practice and legislation;

(h) quality management of procedures and activities to ensure, within the framework of the quality assurance system, compliance with the quality requirements of all activities relating to the clinical trial;

(i) by standard working procedures, detailed written methods of carrying out individual operations in the framework of a clinical trial aimed at achieving uniform implementation of those operations;

(j) an unique identifier assigned by the investigator to each subject in order to prevent disclosure of the identity of the subject of the evaluation;

(k) blindness in a clinical trial means the procedure whereby the trial body and, where appropriate, the examiners or other persons involved in the clinical trial do not have access to information on the assignment of the investigational medicinal product to individual subjects.

(2) In the case of radiopharmaceuticals, all clinical trials shall be conducted in accordance with specific legislation.1)

§ 2

General principles of good clinical practice

(1) The clinical evaluation is carried out in accordance with the ethical rules binding the Czech Republic on membership of the World Health Organisation.

(2) The clinical trial shall be conducted in accordance with the clinical trial protocol set out in Annex 1 ("the protocol") and the Appendices to the protocol.

(3) Only those with education, knowledge and experience necessary for the performance of clinical evaluation tasks may participate in the conduct of a clinical trial.

(4) All information on clinical trials shall be recorded, processed and stored in such a way as to allow accurate reporting, evaluation and verification.

ČÁST DRUHÁ

CLINICAL EVALUATION OF HUMANS

HLAVA PRVNÍ

ETIC COMMISSION

Establishment, composition and activity of the Ethics Commission

§ 3

(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 will immediately notify the State Institute for Drug Control, including further information under Section 35 (3) of the Act.

(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.

(5) Where a clinical trial has been carried out in a health institution for which approval has been given by the Ethics Committee established by the healthcare establishment, the head of the healthcare establishment shall create the conditions for that Ethics Committee to carry out its activities throughout the duration of the clinical trial in that health establishment and where changes in its composition occur to ensure the continuity of its activities and its rights and obligations.

§ 4

(1) The Ethics Commission shall issue its opinions at meetings which it shall announce in advance in the manner described in the written working procedures of the Ethics Committee referred to in paragraph 2. Only those members of the Panel who participate in and are familiar with the clinical trial shall express their opinion. A statement of at least five members of the Ethics Commission, among which there is a non-medical education or professional scientific qualifications, and a non-employment, similar employment relationship or dependent status to the healthcare establishment in which the proposed clinical evaluation will take place, is needed for the adoption of the opinion. The examiners shall not take part in the adoption of the opinion of the Ethics Commission.

(2) The Ethics Committee shall perform its functions in accordance with written working procedures which shall include in particular:

(a) the determination of its composition (names and qualifications of the members) and of the establishment establishing it;

(b) the manner in which meetings are planned, their notification to members of the Ethics Commission and the conduct of meetings;

(c) examination of requests for the approval of the Ethics Committee to initiate the clinical trial and to carry out ongoing supervision of the clinical trial;

(d) the method of determining the ongoing supervision of clinical trials;

(e) rapid assessment and opinion on administrative changes in ongoing clinical trials;

(f) the definition of the manner in which the Ethics Committee accedes to the reporting of investigators, the information obtained from the supervision of the clinical trial or otherwise obtained, and the way in which the Ethics Committee communicates in writing its views on the clinical trial to the examiner or health care institution, the reasons for its opinions and any procedures for reviewing the opinion,

(g) the definition of the manner and time limits by which the Ethics Committee communicates the data required by law and by this Decree to the examiner or contracting entity, to the State Institute for Drug Control and, in the case of the Ethics Committee, 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;

(3) The records kept by the Ethics Commission in accordance with § 35 (12) of the Act must be made available at the request of the authorities which perform the administration under § 6 of the Act and of the foreign supervisory authorities in the field of pharmaceuticals.

(4) Written working procedures, a list of the members of the Ethics Commission and a statement that the Ethics Committee has been established and works in accordance with good clinical practice and legislation shall be provided on request to the examiner, contracting authority or authorities referred to in paragraph 3.

(5) The minutes of the Ethics Commission's deliberations shall contain the date, hour and place of the hearing, the list of members present, the list of other persons invited, the main points of discussion, the record of the opinion, including the manner in which the opinion was adopted, the record of the notification of the possibility of conflicts of interest and the signature of at least one member of the Commission.

(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 inform 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 deceased Ethics Committee is ensured.

§ 5

Granting consent to conduct a clinical trial

(1) The Ethics Committee gives its consent to conduct a clinical trial only on the basis of a written request and after examination of all documentation submitted. A request for consent to conduct a clinical trial shall be submitted to the competent ethics committee by the investigator or sponsor. Documents and supporting documents shall be submitted to the Ethics Commission in a language which is understandable to the members of the Panel.

(2) An Ethics Commission shall be submitted:

(a) the Protocol and any amendments thereto;

(b) the text of the informed consent provided to the evaluation bodies and other written information provided to the evaluation bodies;

(c) procedures for the recruitment of evaluation bodies, in particular advertisements;

(d) a set of information for the investigator containing available data on the safety of the investigational medicinal product;

(e) detailed information on compensation for expenditure and remuneration for evaluation bodies;

(f) a CV of the examiner or other documents certifying his qualifications;

(g) the insurance contract of the assessment body, the investigator and the sponsor pursuant to § 34 (3) (f) of the Act;

(h) other documents requested by the Ethics Commission.

(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 Commission for individual clinical trial sites shall also provide 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.

(7) The opinion of the Ethics Committee contains:

(a) the identification details of the assessed clinical trial, in particular the name of the clinical trial, the indication of the sponsor and the location of the trial, where appropriate the protocol identification number, the date of receipt of the application and the list of the clinical trial sites on which the Ethics Committee has expressed its views and overseen;

(b) a list of the documents evaluated;

(c) the operative part and its justification;

(d) the date on which the opinion is delivered and the signature of at least one member of the Commission who is entitled to do so by written procedure as provided for in Article 4 (2);

(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 bodies of the evaluation referred to in the Protocol and shall indicate whether it makes the inclusion of each individual entity subject subject to its consent; 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 issued by the Ethics Panel on Multi-Centre Evaluation, this shall be indicated, together with a list of clinical trial sites on which it has expressed its views and overseen.

§ 6

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 of revocation of the consent and the signature of at least one member of the commission who is entitled to do so by written procedure of the Ethics Committee.

HLAVA DRUHÁ

TESTING

§ 7

Basic activities examining3)

(1) Before commencing a clinical trial, examiners shall be familiar with the correct use and properties of the investigational medicinal product, as described in the protocol and its Appendices, the investigator information file and other information material provided by the sponsor.

(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 cases of clinical trials where such consent cannot be obtained before the subject is included in the clinical trial, the procedure laid down in Section 34 (8) of the Act and in Section 5 (4) of this Decree shall be followed.

(3) Examiners in good clinical practice

(a) ensure that all persons cooperating in carrying out the clinical trial at the site are sufficiently experienced and adequately qualified and are duly informed of the protocol and its additions, the investigational medicinal products and their tasks in connection with the clinical trial;

(b) keep a written record of the persons it has entrusted with carrying out the tasks relevant to the conduct of the clinical trial;

(c) ensures that adequate medical care is provided to the subject in the event of an adverse event, including a clinically significant deviation of laboratory values from normal values in connection with the clinical trial;

(d) if he or she is informed of the subject's disease in progress, he or she shall inform the subject of the evaluation of that fact;

(e) in the event of the consent of the subject, inform the subject of the participation in the clinical trial of his attending physician;

(f) make reasonable efforts to establish the reasons for the early withdrawal of the subject from the clinical trial without prejudice to the rights of the subject.

(4) The investigator or the authorised person shall keep records of the supply of the investigational medicinal product to the place of clinical trial, the state of stocks of the investigational medicinal product at the place of evaluation, the use by each of the subjects of the evaluation and the return by the contracting entity of the unused investigational medicinal product or any other means of its disposal. These records shall include the date, quantities, lots, shelf life and code numbers assigned to the investigational medicinal product and to the subjects of the evaluation. The examiner shall keep a record showing that the evaluation bodies have received the benefits of the medicinal product listed in the protocol and reporting the treatment of all evaluated medicinal products taken from the contracting authority.

(5) The investigator shall ensure that the investigational medicinal product is used exclusively in accordance with the approved protocol, ensure that each subject is informed of the correct use of the investigational medicinal product and checks, at intervals appropriate for the clinical trial, whether each subject is following the instructions.

(6) If a random selection of subjects (randomisation) is conducted in a clinical trial, the investigator shall ensure that the identification code is only disclosed in accordance with the protocol. If the clinical trial is blinded, the investigator shall immediately inform the contracting entity of any premature unblinding of the investigational medicinal product and document this.

§ 8

Lessons and informed consent of the evaluation body

(1) The details of the training of the evaluation body and the written informed consent are set out in Annex 2. When obtaining written informed consent, the assessment body shall not be unduly affected to participate or continue the clinical trial.

(2) In order to obtain informed consent to participate in a clinical trial, the investigator shall only use and transmit to the subjects information material approved by the sponsor and approved by the relevant Ethics Commission and the State Institute for Drug Control. Such information material shall be updated, agreed and approved whenever new information relevant to the evaluation bodies is available.

(3) The examiner or the person authorised by him before obtaining informed consent shall provide the subject with sufficient time, or, where appropriate, his legal representative, with a decision and an opportunity to raise questions concerning the clinical trial; these questions shall be answered.

(4) The applicant or the person authorised by it shall provide the evaluation body or its legal representative with a copy signed and dated with informed consent, as well as a copy of the written information on the clinical trial intended for the subjects of the evaluation, including any amendments and additions, where appropriate. In the event that the informed consent is provided in addition to the legal representative, the evaluation body shall receive a copy of that consent and the evaluation body.

(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 has no experience in the field of pediatric medicine, it shall ensure the participation of an expert qualified in the field of pediatric medicine in the exercise of supervision.

§ 9

Records and reports

(1) The documents referred to in Section I of Annex 3 shall be available before the start of the clinical trial in the medical establishment where the clinical trial is conducted. This Annex also sets out in Sections II and III the documentation to be kept during and after the completion of the clinical trial. These documents must be available unless otherwise specified in the authorisation for clinical trial.

(2) The investigator shall ensure accurate, complete, legible and timely recording of data in the records of the evaluation bodies and in all reports. The records of the investigator in the records of the evaluation bodies shall be in accordance with the source documents; any irregularities must be explained.

(3) Any amendment or correction to the records of the evaluation bodies shall be indicated by the date, the signature of the person who made the change and, where appropriate, by an explanation; the change or correction shall be added to the original entry. Changes or repairs shall be carried out by the examiner, his or her co-workers, authorised to carry out the changes or repairs, or by the contracting entity of the authorised person, in accordance with the written working procedures of the contracting authority; such modification or repair is confirmed by the signature of the examiner.

(4) Records relating to clinical trials at the place where the clinical trial is carried out shall be accessible to the contracting authorities, the members of the Ethics Commission and the authorised persons of the supervisory authorities referred to in Article 4 (3).

(5) The examiner shall, upon request by the contracting authority, the monitor (§ 20 (3)), the auditor (§ 21 (2)), the Ethics Committee or the inspection offices, provide direct access to all required clinical evaluation records.

(6) The report on the conduct of the clinical trial (Section 38 (10) of the Act) contains the information set out in Annex 4.

(7) The investigator shall without delay inform the contracting authority, the relevant Ethics Commission and the healthcare establishment of any changes significantly affecting the conduct of the clinical trial and / or the increased risk of the subjects.

(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.

§ 10

Notification of serious adverse events

(1) The notification of a serious adverse event to the contracting authority pursuant to Article 38b (1) of the Act shall contain an indication of the place of evaluation, the name or name of the sponsor, the name of the clinical trial and the number of the protocol, the patient's identification, the description of the event, the name of the medicinal product causing the serious adverse event, including the dose administered and the route of administration. If the report is not made in writing, it shall be confirmed without delay by a detailed written report. In immediate and subsequent written reports, the evaluation bodies shall be identified preferably by an identification code.

(2) Adverse events, including laboratory deviations, listed in the protocol as critical of the safety assessment are reported in accordance with reporting requirements and within the time limits specified by the contracting authority in the protocol.

§ 11

Discontinuation of the clinical trial and its termination before any acts provided for in the protocol are implemented

(1) If the clinical trial is interrupted or terminated before any of the operations provided for by the Protocol ("early termination '), the investigator shall immediately inform the subjects of the evaluation and ensure that they are further treated and monitored.

(2) Where the clinical trial is interrupted or terminated under the conditions referred to in paragraph 1, the clinical trial shall:

(a) the examiner, without prior consent of the contracting authority, the investigator, shall immediately inform the State Institute for Drug Control, the contracting authority and the Ethics Commission, or the Ethics Commission, which have spoken about the clinical evaluation concerned; the contracting authority and the ethics committee or ethics committees which have expressed their views on the clinical trial in question shall provide a detailed written explanation;

(b) the contracting authority or the State Institute for Drug Control, the investigator shall immediately inform the Ethics Commission or, where appropriate, the Ethics Commission, which have expressed their views on the clinical trial, which shall provide a detailed written explanation.

(3) If the clinical trial is interrupted or terminated prematurely as a result of a permanent or temporary withdrawal of the approval of the Ethics Commission, the investigator shall immediately inform the medical institution and the contracting entity to which he shall provide a detailed written explanation.

(4) The investigator 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, unless the cases referred to in paragraphs 2 and 3 are concerned.

HLAVA TŘETÍ

ENTERTAINMENT

§ 12

Basic activities of the contracting authority

(1) The contracting authority shall ensure the establishment and maintenance of quality assurance and management systems and the use of written standard working procedures ensuring that clinical trials, including the conduct of laboratory tests and data handling, are carried out and data are collected, documented, processed, evaluated and reported in accordance with the Protocol, the principles of good clinical practice and specific legislation, 4) in order to ensure their credibility and accuracy. Where a contractual research organisation participates in carrying out a clinical trial, that organisation shall have in place a quality assurance and management system similar to that of the contracting entity.

(2) The contracting authority shall designate the investigator, 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 conducted. The contracting authority shall agree with the examiner, health care institution or other persons involved in the clinical trial by a written contract, which may also be annexed to the Protocol, the conditions for carrying out the clinical trial, including its financing and reimbursement of the costs of treatment in the event of injury to the subject in connection with his participation in the evaluation, the responsibility for dealing with the Ethics Commission or the State Institute for Drug Control, the retention of documentation and reporting and information. Prior to the conclusion of a clinical trial contract, the sponsor shall provide the examiner or health care establishment with a protocol and an updated set of information for the investigator and shall provide sufficient time to familiarise itself with the protocol and other information provided.

(3) In a written contract between the contracting authority and the examiner, the contracting authority shall ensure that the contract contains an undertaking by the investigator that:

(a) conduct clinical trials in accordance with good clinical practice, relevant legislation, protocol agreed by the contracting authority and opinion of the Ethics Commission;

(b) comply with the procedures for recording and reporting data.

(4) In addition, the contracting authority shall ensure that, in a written contract between the contracting authority and the examiner or health care institution, it indicates that:

(a) the basic documents relating to the clinical trial shall be kept until the sponsor has notified the examiner or the medical institution that they are no longer necessary;

(b) access to medical facilities carrying out clinical trials, source documents and reports for monitoring, audits, inspections of the State Institute for Drug Control or Foreign Audit Offices shall be granted.

(5) In addition, the contracting authority shall ensure, by written contract, a clear definition of the obligations, functions and activities it delegates to the contract research organisation, where such organisation participates in the conduct of the clinical trial, responsibility for the accuracy and completeness of the data obtained by the contracting authority, but shall remain intact.

(6) Before commencing a clinical trial, the sponsor shall define, establish and distribute all obligations and functions relating to the clinical trial and shall ensure that only sufficiently qualified and experienced persons participate in all activities related to the preparation, implementation, evaluation, monitoring and auditing of the clinical trial, so that such persons are informed of their rights, duties and, where appropriate, functions and that their qualifications are documented.

(7) The contracting authority shall establish a suitably qualified and readily available physician to provide consultations on health problems and issues arising from clinical trials.

(8) The protocol, the choice of dosage form, the duration and route of administration of the investigational medicinal product should be supported by sufficient data on safety and efficacy from non-clinical trials and / or clinical trials.

(9) The contracting authority shall update the investigator's information file in case it finds new information on the investigational medicinal product.

(10) If the sponsor finds that there is a breach of the study protocol, standard working procedures, principles of good clinical practice, legislation or requirements of the State Institute for Drug Control by examiners, medical establishments or other persons involved in the clinical trial, he shall without delay take action to ensure that the deficiencies are remedied. If the monitoring or audit has revealed a serious or permanent breach as per the previous sentence on the part of the examiner or medical institution, the sponsor shall terminate the investigator's participation in the clinical trial or terminate the clinical trial at that point.

(11) Where the contracting authority is also an examiner, the provisions applicable to the examiner shall apply to it, with the exception of paragraph 4.

(12) In the case of a clinical trial which takes place in several places, the contracting authority shall in particular ensure that:

(a) prior to the initiation of the clinical trial, the responsibilities of the coordinating investigator, if any, and other participating examiners shall be documented;

(b) all examiners shall obtain guidance on compliance with the protocol, a single set of standards for the assessment of clinical and laboratory results and for the completion of the records of the evaluation bodies;

(c) communication between examiners is allowed;

(d) the examiners are informed of the serious unexpected adverse effects of the investigational medicinal products that occurred at other evaluation sites;

(e) a request for the opinion of the Ethics Commission shall be submitted to a single Ethical Commission for Multicentre Evaluation.

(13) The contracting authority shall ensure that each evaluation body has given its written consent to direct access to its initial medical documentation for the purpose of monitoring, auditing, Ethics Commission inspections and inspection of the supervisory authority in connection with the clinical evaluation.

§ 13

Application for authorisation and notification of a clinical trial to the State Institute for Drug Control

(1) The application for authorisation of a clinical trial or for the notification of a clinical trial (Section 37 (2) of the Act) is 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 or notification.

(2) The application or notification of a clinical trial shall be made in duplicate, unless otherwise provided in specific cases by the State Institute for Drug Control, the following documentation:

(a) the Protocol and any additions thereto containing the particulars listed in Annex 1;

(b) written information to the investigator, either in the form of a set of information for the examiner, containing the information referred to in Annex 5, or in the form of a summary of product characteristics;

(c) written informed consent of the subject or his legal representative in the Czech language with any additions;

(d) written information addressed to the subjects of the evaluation, including the instruction of the subject or his legal representative in the Czech language;

(e) the records of the subjects of the evaluation;

(f) whether the clinical trial has already been given an unfavourable opinion by an ethics commission or a foreign supervisory authority;

(g) pharmaceutical data on investigational medicinal products as set out in Annex 6;

(h) in the case of a multi-centre clinical trial, information on which Ethics Committee for Multi-Centre Assessment has been submitted for an opinion.

In the case of clinical trials not aimed at obtaining evidence for the marketing authorisation or development of a medicinal product, or of clinical trials of a specific nature (compact use), the submission of a complete dossier shall not be required.

(3) If the clinical trial subject to authorisation and the investigational medicinal product is a genetically modified organism, 5) it shall be submitted together with the application, or before the authorisation is granted, proof of the registration of the genetically modified organism in the list of genetically modified organisms and products approved for circulation in the Czech Republic under specific legislation. 6) The application shall be accompanied by a risk assessment under a specific legislation. 7)

(4) At the request of the State Institute for Drug Control, the sponsor shall provide the additional supporting documents necessary for the assessment of the clinical trial. The State Institute for Drug Control may notify the various parts of the required documentation as referred to in paragraph 2, the procedure characterising the different types of clinical trial and the relevant requirements and supporting documents by publication in its information medium.

§ 14

Clinical trial, data collection and record keeping

(1) In the course of a clinical trial, the contracting authority shall continuously evaluate the clinical trial procedure, the safety of the investigational medicinal product and, where appropriate, the critical efficacy parameters and, on the basis of the findings, shall take appropriate measures, including changes in or termination of the clinical trial conditions. For the evaluation of the clinical trial procedure, including the evaluation of safety data and critical efficacy parameters, the contracting authority may set up an independent panel continuously evaluating the data. The Panel recommends that the sponsor continue, modify or stop the clinical trial. The Commission shall work in accordance with written working procedures and shall keep written records of its deliberations.

(2) When using an electronic or remote management system for clinical trial data, the contracting authority shall:

(a) ensure and demonstrate that these electronic systems meet the criteria for completeness, accuracy, reliability and are suitable for the purpose;

(b) maintain standard operating procedures for the use of such systems;

(c) ensure that the proposed systems allow data changes in such a way that they are documented and the input data are not deleted;

(d) maintain a security system preventing unauthorised access to data;

(e) keep a list of persons authorised to make changes to the data;

(f) ensure adequate data backup;

(g) ensure the blindness of data if the clinical trial is blinded for the duration of the blind clinical trial.

(3) Where data or observations obtained during a clinical trial are further processed, comparison of original data and observations with processed data shall be possible.

(4) The contracting authority shall use the unique identifier of the evaluation bodies to identify all the monitoring data of each evaluation body.

(5) The contracting authority shall ensure that the documentation referred to in Annex 3 is drawn up and maintained before and during the clinical trial. Any transfer of ownership of data obtained from a clinical trial and any interruption of clinical development of the investigational medicinal product shall be notified by the contracting authority to the State Institute for Drug Control.

(6) After completion of the clinical trial, the contracting authority shall keep the documents listed in Annex 3.

Citation	Decree of the Ministry of Health and the Ministry of Agriculture 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	29.12.2000
Effective from	29.12.2000
Effective until	-
Status	Valid

Decree of the Ministry of Health and the Ministry of Agriculture, which provides for good clinical practice and closer conditions for clinical evaluation of pharmaceuticals

Contents

ČÁST PRVNÍ

§ 1

§ 2

ČÁST DRUHÁ

HLAVA PRVNÍ

§ 3

§ 4

§ 5

§ 6

HLAVA DRUHÁ

§ 7

§ 8

§ 9

§ 10

§ 11

HLAVA TŘETÍ

§ 12

§ 13

§ 14

Contents

Comments 0

Regulation Information

Partner Websites

Favorites

Browsing History