The Medicines for Human Use (Clinical Trials) Regulations 2004

PART 1APPLICATION FOR ETHICS COMMITTEE OPINION

1.  An application document including the following information or, in each case, an explanation of why that information is not being provided—

(a)the reference number of the ethics committee to which the application is made;

(b)particulars identifying the trial including—

(i)the number allocated to the trial on the European database referred to in Article 11 of the Directive, and

(ii)full and short titles of the trial;

(c)the following particulars relating to the trial design—

(i)a summary of the trial, including justification and relevance, and the methodology to be used,

(ii)the primary, and any secondary, research hypothesis,

(iii)statistical analysis and justification for the numbers of subjects to be recruited for the trial, and

(iv)details of the process for peer review of the scientific value of the trial;

(d)brief details of any plans to conduct the trial outside the UK and any authorisation given in relation to the trial by a competent authority of an EEA State in accordance with Article 9 of the Directive;

(e)the name and address of the sponsor;

(f)details of any arrangements under which the sponsor has delegated any of his responsibilities in relation to the proposed trial;

(g)the financial arrangements for the trial, in particular—

(i)sources of funding for the trial and information on financial or other interests of the applicant relevant to the trial,

(ii)the arrangements for remuneration of, or re-imbursement of expenses incurred by, subjects,

(iii)any provision for compensation in the event of injury or death attributable to the trial,

(iv)details of any insurance or indemnity to cover the liability of the sponsor and investigator, and

(v)summary details of any financial arrangements between—

(aa)the sponsor or person funding the trial and the investigator, and

(bb)the sponsor or person funding the trial and the owner or occupier of the trial site;

(h)arrangements for the recruitment of subjects, including the materials to be used;

(i)the criteria for inclusion and exclusion of patients, including justification for recruiting from vulnerable groups;

(j)in the case of Phase I trials, methods for recording and verifying health status for healthy volunteers;

(k)procedures for checking simultaneous or recent involvement of potential subjects in other trials;

(l)details of any relationship between subject and investigator which may be relevant for the purposes of an ethical opinion;

(m)details of—

(i)any proposed additional investigational procedures or other interventions over and above those required for normal clinical care, and

(ii)any aspect of normal clinical care to be withheld or other deviation from normal treatment, and

(iii)the plan for treatment or care of subjects once their participation in the trial has ended;

(n)the procedures for—

(i)providing information to potential subjects, including a contact point where additional information can be obtained about the trial and the rights of trial subjects,

(ii)providing subjects with updated information during and (where relevant) after the trial, and

(iii)obtaining informed consent;

(o)details of the arrangements for access to confidential data about the subjects and the arrangements to protect subjects' privacy;

(p)the rules for terminating or concluding the trial before—

(i)the date for the conclusion of the trial specified in the protocol, or

(ii)the event specified in the protocol as the event which indicates that the end of the trial has occurred;

(q)any agreement on—

(i)the access by the investigator or his team to the data produced by the trial, and

(ii)the policy for publication of that data;

(r)an assessment of the ethical issues relating to the trial, including—

(i)the importance of the trial and of the new knowledge to be gained,

(ii)an assessment of the potential benefits, and

(iii)an assessment of the possible risks for the subjects;

(s)details relating to the chief investigator and each investigator, including—

(i)experience in conducting research, and

(ii)any potential conflicts of interest; and

(t)details of any proposed trial site and its suitability for conducting the trial.

2.  A document containing the particulars specified in paragraphs 1 to 4 and 6 to 9 of Part 2 of this Schedule.

3.  The following documents or, in each case, an explanation of why that document is not being provided—

(a)the protocol;

(b)the investigator’s brochure for the proposed trial or, where the investigational medicinal product has a marketing authorisation and the product is to be used in accordance with the terms of that authorisation, the summary of product characteristics relating to that product;

(c)any document providing evidence of any insurance to cover the liability of the sponsor and investigator;

(d)copies of the advertisement material for recruitment of research participants;

(e)in the case of advertising contained on video or audio cassettes, a copy of the script for that advertising;

(f)a copy of any letter inviting a subject to participate in the trial;

(g)a copy of any questionnaire, diary or sample card to be completed by the subject in writing;

(h)a copy of all written information to be given to a potential subject or their legal representative prior to seeking informed consent;

(i)a copy of the form to be used to record the consent of a subject or their legal representative;

(j)a copy of any letters or other written information to be sent to any person who normally provides a subject’s clinical care;

(k)a summary curriculum vitae for the chief investigator and each investigator.