The EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Romania

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1 The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Romania Question 1: What laws or regulations apply to an application for conducting a clinical trial in Romania? EUROPEAN GUIDELINES European Commission Directive 2001/20/EC (the Clinical Trials Directive ) transposed by Minister of Health Order (MHO) 904/2006. European Commission Directive 2003/94/EC on good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use transposed by MHO 905/2006. European Commission Directive 2005/28/EC (the GCP Directive ) transposed by MHO 903/2006. ICH E6: Good Clinical Practice: Consolidated guideline, CPMP/ICH/135/95 transposed by NMA Scientific Council Decision (SCD) 39/2006. Detailed guidance on application for authorization of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial transphosed by NMA SCD 49/2006. Good manufacturing practices - ANNEX 13 Manufacture of investigational medicinal products - NMA SCD 1/2009 (ANNEX 13). Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use - NMA SCD 26/2007. Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - NMA SCD 15/2008. Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials - NMA SCD 7/2009. Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use - NMA SCD 50/2006.

2 ROMANIAN SPECIFIC NMA SCD 11/2009 on approval of Regulations concerning authorisation by the National Medicines Agency of clinical trials/ notification to the National Medicines Agency of non-interventional clinical trials conducted with medicinal products for human use in Romania provides procedure steps for assessment and approval of an Application for Clinical Trial. MHO 912/2006 on approval of the Regulation for the authorisation of clinical sites for conducting clinical trials on medicinal products for human use Question 2: Which government, legal or authoritative body or bodies is or are responsible for the establishment and/or accreditation of (research) ethics committees for IMPs, and for their supervision and quality? Are there different (research) ethics committees reviewing other projects? The National Ethics Committee for Clinical Trials is an independent body and it is under the direct authority of the Minister of Health. There are a few other ethics committees organized in hospitals with accreditation for clinical trials, but these are used only in consultative matters. Question 3: What is the process for achieving clinical trial authorisation from the competent authority in Romania? NMA SCD 11/2009 on approval of Regulations concerning authorisation by the National Medicines Agency of clinical trials/notification to the National Medicines Agency of non-interventional clinical trials conducted with medicinal products for human use in Romania provides procedure steps for assessment and approval of an Application for Clinical Trial. - Validation of the CTA dossier; if the documentation is complete, the application is accepted and it shall receive a NMA registration number. - The authorisation tariff for admission, established through the NMA Administrative Council Decision, shall be paid after having accepted the application for authorisation. - After the money enters into the NMA account, the evaluation procedure of the documentation needed in clinical trial authorisation shall start. The deadlines are those mentioned in Minister of Health Order (MHO) 904/ If, following evaluation of documentation, additional information is needed, the NMA shall thereof inform the applicant in writing. - The authorisation/rejection of the clinical trial authorisation is extended compared to the deadline mentioned in Minister of Health Order (MHO) 904/2006 with the duration of time elapsed as of admission of the application letters containing applications issued by the applicant and until the NMA receipt of the solicited information. Romania - 2

3 Question 4: What is the process for obtaining ethical review of a clinical trial protocol by a competent (research) ethics committee in Romania? According to detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use - NMA SCD 50/2006. Question 5: Is there a single organisation to which to apply for ethical review of a clinical trial for an investigational medicinal product, regardless of whether this is for a single site or multiple sites? It is a single organisation: National Ethics Committee for Clinical Trials (NECCT). Question 6: What is the website for the organisation that issues guidelines on the ethical review of a clinical trial for an investigational medicinal product? NECCT has not a website yet. Question 7: Is there a procedural interaction between the national or local competent authority and the (research) ethics committee during the approval process? Question 8: Does the application to the REC and to the competent authority have to be submitted in parallel, or, if not, in which order? The clinical trial application to the competent Authority and to the Ethics Committee/s may be submitted in parallel. Question 9: How many (research) ethics committees are there in Romania? To receive the approval to begin a clinical trial, it is mandatory to obtain the favourable opinion of NECCT. The other local EC s have only consultative tasks. Question 10: How are RECs funded in Romania? Do they charge fees? If yes, what is their scale of fees? NECCT is funded in Romania by a NGO which charges the fees from the CRO s and with this money assures the logistics of the NECCT. The scale of fees is between 170 and 670. Romania - 3

4 Question 11: Who is responsible for submitting the request for ethical review to the competent (research) ethics committee for single-site and for multi-site clinical trials? The request is submitted by the sponsor or an applicant appointed by the sponsor. Question 12: How is a single opinion achieved for multi-site studies? Only the NECCT can approve multi-site studies. Question 13: How many members serve on a REC? Twelve. Question 14: How many members constitute a quorum? Seven. Question 15: How are REC members appointed? The EC s members are proposed by the president of NECCT, according to their CV s and approved by the Minister of Health. Question 16: How is the independence of members ensured? The independence of the members is ensured by the independence of NECCT. Question 17: How are conflicts of interest of REC members avoided? Every EC s member has to fulfil an interest declaration. Question 18: What backgrounds and/or qualifications of members are actively sought? In the NECCT the members are physicians with different specialities, pharmacists and an attorney in law. There are also a representative of the religious cults and one for the consumers. Question 19: How do RECs obtain specialist expertise? NECCT can ask in some situations an specialist expertise, specially when the field of the trial refers to a rare pathology or in other particular situations. Romania - 4

5 Question 20: What are the training requirements for members of RECs? The physicians and the pharmacists are professors and/or senior specialists in different fields, but there are no specific training requirements for members of RECs. Question 21: What training programmes are available for REC members in Romania? There are no training programmes for REC members in Romania. Question 22: What are the timelines for the assessment of single- and multi-site studies? Sixty days for both single- and multi-site studies. Question 23: How are substantial amendments submitted during the review process dealt with? The substantial amendments are submitted by correspondence during the review process. NECCT has to communicate to the applicant the reception and the approval (or not) of the amendments. Question 24: How does a REC assess the suitability of investigators and of sites? The suitability of investigators and of sites is assessed taking in account the approval of the Ministry of Health (for the sites) and CV s for investigators. Question 25: How are the requirements for (research) ethics committees to review the contractual or financial arrangements in clinical trials for both investigators and hospitals handled? The clinical study financial agreements between the CRO, sponsors, hospitals and investigators, have to be forwarded to NECCT simultaneously with the application file. Question 26: How are the requirements for (research) ethics committees to review the compensation arrangements for study subjects handled? Until now compensation arrangements have been approved only for healthy volunteers; now we take in account more differentiated strategies. Romania - 5

6 Question 27: Is there an ongoing quality assurance process (e.g. audits, inspections, internal SOP) for (research) ethics committees in Romania? Question 28: Is there an appeal mechanism? Question 29: How do RECs deal with SUSAR reports and Annual Safety Reports? NECCT receive the SUSAR reports and the Annual Safety Report. Question 30: How are substantial amendments defined? According to: Detailed guidance on application for authorization of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial transposed by NMA SCD 49/2006. Question 31: What are the indemnity insurance requirements for research projects? The insurance must cover any possible damages caused to the subjects following their participation in the trial. Question 32: What are the indemnity insurance requirements for (research) ethics committee members themselves? We have no such requirements for REC members. Question 33: How is informed consent obtained from vulnerable subjects who are potentially to be involved in a clinical trial? The informed consent of vulnerable subjects to participate in a clinical trial may be obtained from the legal representative and must be the presumed expression of the will of the subject, provided that the subject has received information adequate to his/her capacity of comprehension; furthermore it may be withdrawn at any time. Question 34: How do RECs assess the progress and outcome of research projects that they have approved? The outcomes of the research projects are not received by NECCT. Romania - 6

7 Question 35: How does the REC ensure reception of the Annual Safety Report and the Summary of the Final Report of a research project that it has approved? The NECCT receives the Annual Safety Reports. It does not receive the final reports. Question 36: Do national regulations in Romania allow research on healthy volunteer children (subjects under 16)? Yes, always with the consent of both parents. Question 37: Do national regulations in Romania allow payment, (other than expenses), to children taking part in research? See above. Question 38: Do RECs invite or allow a) applicants or b) observers to attend committee meetings? Yes. Question 39: Are the minutes of (research) ethics committee meetings made public? No, because NECCT has not yet a website. Question 40: Is there any scope for Chairman s actions in between meetings? Yes, because the Chairman is also file reviewer of the submitted documents. Question 41: Do (research) ethics committees ever appoint subcommittees for any specific purpose? Question 42: Is there a national policy on the registration of clinical trials before they start? Question 43: If the answer to Question 42 is yes, do (research) ethics committees have any role to play in reviewing such registration? N/A Romania - 7

8 Question 44: If the answer to Question 42 is yes, is this register of clinical trials made available to the public? N/A Validated May EFGCP aisbl all rights reserved Romania - 8

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