Title: Assessment of Study Feasibility Manual: RI MUHC Policies and Procedures Human Research SOPs Originating Dept/ Service: RI MUHC Division of Clinical Research SOP: New Revised Reviewed Effective Date: 08 October 2009 Key Words: Assessment, Study Feasibility Approved by : Supervisor/Manager Risk/Ethics Sr. Mgmt Committees Board/Councils Scope: Research wide Dept. specific Other: Research involving Human Subjects Site Specific: Yes No Distributed to: Staff Mgmt Others Objective(s) The objective of this standard operating procedure (SOP) is to provide the research team with some tools with which to evaluate the feasibility of a clinical study. This SOP may also inform the feasibility of other types of research studies. Persons/Areas Affected This SOP concerns the MUHC research community (employees, investigators, physicians, management, consultants, students, volunteers or other persons) involved in conducting research with human subjects. Definitions Sponsor: An individual, company, institution or organization which takes responsibility for the initiation, management or financing of a human research study (modified from ICH, E6 1.53). Sponsor-Investigator: An individual who both initiates and conducts alone or with others a research study. The term does not include any person other than an individual (it does not include a corporation or an agency). The obligations of a Sponsor-Investigator include both those of a Sponsor and those of a Principal Investigator/Qualified Investigator (ICH, E6 1.54). Principal Investigator (PI): A person responsible for the conduct of the research study at a study site. If a study is conducted by a team of investigators at the same study site, the Principal Investigator is the responsible leader of the team (ICH, E6 1.34). Qualified Investigator: The person responsible to the Sponsor/Sponsor-Investigator for the conduct of a clinical research study with an experimental drug at the study site, who is entitled to provide health care under the laws of the province where that study is located, and who is (HC, C.05.001): SOP06EN02_Assessment of Study Feasibility_08Oct09 Page 1 of 8
In the case of a clinical research study with an experimental drug to be used for dental purposes only, a physician or dentist and a member in good standing of a professional medical or dental association; In any other case, a physician and a member in good standing of a professional medical association. Procedures 1. Clinical Study Assessment 1.1.1. Assessment of study feasibility can be based on a list of questions, the answers to which will allow the Principal Investigator/Qualified Investigator to make an informed decision regarding the feasibility of the study at his site. The questions, listed in Appendix 1, Clinical Study Feasibility Check List, are the following: 1.2. Is this protocol scientifically, technically and ethically feasible? 1.2.1. My field of practice permits me to fulfill my responsibilities according to the requirements of the protocol. 1.2.2. This protocol can be conducted in compliance with the local authorities and the requirements of my site. 1.2.3. Subject eligibility criteria are realistic and well defined in the protocol. 1.2.4. If required, the comparative experimental drug is available in my area. 1.2.5. This protocol is consistent with local ethical practices. 1.3. Do we have the population targeted by this protocol? 1.3.1. Availability of the population targeted for this protocol, has been verified at my site. 1.3.2. Competing clinical studies, targeting the same population (same population, same type of study, same time period as other studies, etc.) have been evaluated in my institution. 1.3.3. The capacity to recruit the required number of appropriate subjects, within the established time limits, has been checked. 1.3.4. According to the protocol, and if required, the number of potential subjects outside my site has been discussed (type of advertisement, etc.) 1.3.5. Protocol requirements which have an impact upon the consent of subjects to participate in the study have been evaluated (number of visits, number of hours per visit, etc.) 1.3.6. Test or treatment periods have been evaluated, taking the calendar and potential holiday periods into account. SOP06EN02_Assessment of Study Feasibility_08Oct09 Page 2 of 8
1.4. Are there sufficient resources within the research team? 1.4.1. The Principal Investigator/Qualified Investigator has decided which tasks can be delegated to Co-investigators or Study Coordinators. 1.4.2. The Principal Investigator/Qualified Investigator should be able to rely on a sufficient number of qualified employees for the anticipated duration of the study in order for it to be conducted properly and safely. 1.4.3. The list of technical and professional personnel required for the study undertaking has been established and all are qualified and available. 1.4.4. The budget for the research team has been assessed and is acceptable. 1.5. Do we have the time? 1.5.1. The Principal Investigator/Qualified Investigator or his delegate has sufficient time to personally see and treat subjects. 1.5.2. The Principal Investigator/Qualified Investigator or his delegate has sufficient time to supervise the research team. 1.5.3. The Principal Investigator/Qualified Investigator or his delegate has sufficient time to ensure that the data recorded in the CRFs and all other required reports are accurate, complete, legible and submitted rapidly to the Sponsor/Sponsor-Investigator. 1.5.4. The Principal Investigator/Qualified Investigator or his delegate has sufficient time to interact with the Sponsor/Sponsor-Investigator and the research team. 1.5.5. The Principal Investigator/Qualified Investigator or his delegate has sufficient time to conduct and complete the study appropriately within the established timeframe. 1.5.6. It is important not to underestimate the involvement of the Principal Investigator/Qualified Investigator in the conduct and supervision of a clinical study for which he is ultimately responsible. 1.6. Do we have adequate facilities? 1.6.1. ICH principle 4.2.2 stipulates that the Principal Investigator/Qualified Investigator should be able to count on adequate facilities for the expected duration of the study: do we have access to the necessary facilities and equipment or do we need specific equipment? 1.6.2. The working space required for study personnel has been evaluated. 1.6.3. The space required for subject recruitment and follow-up has been verified. 1.6.4. The space to securely store subjects study records and clinical study material has been evaluated. 1.6.5. All material necessary to the study is available on site. SOP06EN02_Assessment of Study Feasibility_08Oct09 Page 3 of 8
1.6.6. Protocol required specific medical material as well as on-site, available medical material have been verified. 1.6.7. Space for storage of the experimental drug (pharmacy, etc.) has been verified. 1.6.8. Local laboratory facilities or other services required in protocol have been verified. 1.6.9. Communications and/or written agreements with other services, if necessary, have been verified. It is suggested to keep these communications and/or written agreements with the essential study documents as described in SOP 03. 1.6.10. The space required for monitoring, auditing or inspecting has been evaluated. 1.7. Do we have sufficient financial resources? 1.7.1. Have the following study costs been accounted for: a. Personnel and time (have we thought of coordinator s administrative costs for time spent preparing study documentation for submission to the REB/ Scientific review and, if applicable, for contracts review, Health Canada submission, Serious Adverse Event (SAE) reporting, follow-up with subjects and time spent on screen failure subjects, etc.) b. Subject compensation c. Purchase of any necessary equipment d. MUHC department services (if applicable, e.g. pharmacy, radiology, laboratories, medical records). Verify with each department for the fees that apply. e. Monitoring f. Archiving g. Data management services h. Institutional overhead and study review fee, if applicable i. Start-up costs j. Educational staff training 2. Initiation Visit 2.1.1. In the course of an initiation visit, familiarity with the protocol, objectives and procedures, subject inclusion and exclusion criteria, knowledge of the experimental drug if applicable, Good Clinical Practice and legal obligations of the research team should all be assured. The following specific items can also be discussed during these visits: a) Management of adverse events and serious adverse events and management of adverse reaction and serious adverse reaction; b) Management of pharmacy, laboratory, radiology, medical records or other services involved, if applicable; The department s personnel should be invited to the initiation visit if they need to be informed of specific requirements. c) Monitoring and inspection activities; d) Management of case report forms; SOP06EN02_Assessment of Study Feasibility_08Oct09 Page 4 of 8
e) Management of study essential documents; f) Subject informed consent form procedures; g) Data management; h) Management of biological samples; i) Any other protocol-specific item. 2.1.2. As described in ICH division 8, Essential Documents for the Conduct of a Clinical Trial, subsection 8.2.19 and 8.2.20, a monitoring report should be filed proving that the facilities are suitable for the conduct of the study and that study procedures have been reviewed with the Principal Investigator/Qualified Investigator and personnel responsible for the study. 2.1.3. A copy of this monitoring visit report, written by the sponsor/sponsor-investigator or delegate should be kept with the essential study documentation, as described in SOP 03 References ICH E6: International Conference on Harmonisation (ICH) Requirements for Registration of Pharmaceuticals, Harmonised Tripartite Guideline, E6: Guideline for Good Clinical Practice (GCP), May 1996. Appendix Appendix 1-Clinical Research Study Feasibility List SOP06EN02_Assessment of Study Feasibility_08Oct09 Page 5 of 8
APPENDIX 1 SOP06EN02 Protocol Title: Clinical Research Study Feasibility Check List Protocol Number: Questions Yes No N/A Comments Part 1 Science, technique and ethics The protocol has been evaluated for scientific merit The protocol is technically feasible. The protocol is compatible with the medical field, local authorities and site requirements. The protocol admissibility criteria are realistic and well defined in the protocol. If required, the comparative drug is available in my region. The protocol is compatible with the local ethical practices. Part 2 Subjects The targeted population is present at my site Competitive studies at my site have been evaluated The number of available subjects to recruit within the time limits is confirmed (medical files, computerized listing) Subjects availability outside my site (advertising) has been estimated, if required The evaluation of the subjects participation agreement vs. the protocol requirements has been completed. Treatment or tests period are acceptable Part 3 Personnel Availability PI/delegate: available time to see and treat the patients. PI/delegate: available time to supervise his team PI/delegate: available time to generate, review and submit the study data. PI/delegate: available time to interact with the Sponsor/Sponsor-Investigator. Evaluation of the required qualified personnel for the study. Page 1 of 3 SOP06EN02_Assessment of Study Feasibility_08Oct09 Page 6 of 8
Protocol Title: Clinical Research Study Feasibility Check List Protocol Number: Part 4 Resources Evaluation of tasks delegations Questions Yes No N/A Commentaries Evaluation of the available personnel vs. the study duration List of required technical and professional personnel Evaluation of the budget (team remuneration) Part 5 Facilities and equipment Evaluation of the personnel working space Evaluation of the subjects recruiting and follow-up space Evaluation of the space for (secure) storing of the subjects study records Evaluation of the space for secure storing of the clinical study material Available material in line with the protocol requirements Available medical equipment in line with the protocol requirements Secure preserving space for the experimental drug (pharmacy or other) Local laboratories compatibility Other services compatibility Written agreement confirmation with other site services Evaluation of the space for monitoring activities or others Part 6 Financial Resources Personnel and staff training Subject compensation Purchase of any necessary equipment Page 2 of 3 SOP06EN02_Assessment of Study Feasibility_08Oct09 Page 7 of 8
Clinical Research Study Feasibility Check List Protocol Title: Protocol Number: Questions Yes No N/A Commentaries Part 6 Financial Resources (cont d) MUHC department services (if applicable - e.g. pharmacy, radiology, laboratories, medical records) Monitoring Archiving Data management services Institutional overhead and study review fee, if applicable Start-up costs Educational staff training Others Part 7 Others Page 3 of 3 SOP06EN02_Assessment of Study Feasibility_08Oct09 Page 8 of 8