SOP: New Revised Reviewed Effective Date: 08 October Key Words: Development, Approval, Implementation, Management, Review, SOP

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1 Title: Development, Approval and Review of SOPs Manual: RI MUHC Policies and Procedures Human Research SOPs Originating Dept/ Service: RI MUHC Division of Clinical Research SOP: New Revised Reviewed Effective 08 October 2009 Key Words: Development, Approval, Implementation, Management, Review, SOP 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 outline the development, approval, organization, implementation and management of all RI MUHC Human Research SOPs. 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. Definition(s) I. Standard Operating Procedure (SOP): Detailed, written instructions to achieve uniformity in the performance of a specific function (modified from ICH, E6 1.55). II. McGill University Health Centre (MUHC): Merger of five teaching hospitals affiliated with McGill University The Montreal Children's Hospital, The Montreal General Hospital, The Royal Victoria Hospital, The Montreal Neurological Hospital, and The Montreal Chest Institute. III. IV. Research Institute of the MUHC (RI MUHC): Grouping of each of the respective research units of the MUHC. Human Research: A systematic investigation to establish and communicate facts, principles, understanding or generalizable knowledge which may include projects where data are derived from the collection of information through any interaction or intervention with a living individual; the secondary use of data previously collected from human subjects; identifiable private information about an individual; human remains, cadavers, human organs, tissues and biological fluids, embryos or fetuses (Modified from McGill Policy on Ethical Conduct, 3.1). V. Clinical Research: Patient-based research that refers primarily to the study of drugs, devices or other technologies and interventions in human subjects. VI. 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). SOP01EN02_Development, Approval and Review of SOPs_08Oct09 Page 1 of 9

2 VII. VIII. IX. 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 (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 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 ): a. 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; b. In any other case, a physician and a member in good standing of a professional medical association. Procedures 1. Institutional Responsibilities concerning RI MUHC Human Research SOPs 1.1. Associate Director of Clinical Research, RI MUHC The Associate Director of Clinical Research, RI MUHC is responsible for: Completing and updating Appendix 3, Task delegation or Assignment of Responsibilities Form, if any tasks or responsibilities are delegated Reviewing and approving Human Research SOPs that will be used in the institution according to validation procedures; Reporting the approved Human Research SOPs to the RI MUHC Board of Directors RI MUHC Research Officer The RI MUHC Research Officer is responsible for: Drafting and updating Human Research SOPs that will be used in the institution; Informing members of the Research Ethics Board (REB) and the human research community that the SOPs will be implemented within the institution; At the time of implementation of each SOP, offering training on the validated SOP to the MUHC human research community; In the event that a SOP is modified, informing MUHC human research community regarding the change(s) MUHC Sponsor-Investigator or Principal Investigator/Qualified Investigator The MUHC Sponsor-Investigator or Principal Investigator is responsible for: Ensuring that, during the research study, the research team, which will be under his supervision, will comply with the SOPs. SOP01EN02_Development, Approval and Review of SOPs_08Oct09 Page 2 of 9

3 2. Flow Chart of RI MUHC Human Research SOP Development and Approval RI MUHC Research Officer Development of Human Research SOPs RI MUHC Human Research SOP Committee Revision and adaptation of SOPs Associate Director of Clinical Research, RI MUHC Validation of Human Research SOPs REFUSAL APPROVAL RI MUHC Board of Directors Review report of SOPs prepared by Associate Director of Clinical Research, RI MUHC RI MUHC Research Officer Implementation of SOPs Training of research personnel in validated SOPs Annual revision of Human Research SOPs Periodic updates to Human Research SOPs SOP01EN02_Development, Approval and Review of SOPs_08Oct09 Page 3 of 9

4 3. General Organization of RI MUHC Human Research SOPs The SOPs are produced in electronic format. The same format is also used to update the SOPs The date format used is: day (dd), month in letters (mmm) and year (yyyy) The version available on the RI MUHC Website or Portal will be the latest updated version SOPs and appendices are the property of the RI MUHC Copies of each official SOP and corresponding validated appendices will be kept at the RI MUHC (Division of Clinical Research). 4. Development and Drafting of the RI MUHC Human Research SOPs 4.1. Content of SOP and appendices The Following items will apply to all SOPs Reference to the masculine gender shall mean either gender The writing style is in the active context and the present tense Titles and functions rather than names, are used RI MUHC identification and SOP number appear on the top of every page All SOP and appendix pages are numbered on the bottom right corner of each page, e.g. Page 1 of x The SOP items in sequence are: c. Objective(s), describes the objective(s) for the SOP; d. Persons/Areas affected, describes the persons affected by the SOP; e. Definition(s) (if applicable), includes definitions specific to the SOP; f. Procedures, describes instructions for common procedures conducted within the scope of the SOP that apply to the institution. The procedures show the various steps, describe a sequence of ordered activities, itemize critical processes and supply a framework for decision-making; g. References (if applicable), outlines SOP policies that might interact with, or impact on, the described SOP; h. Appendices (if applicable), do not have a precise format. They are adapted to the specific needs of each SOP Numbering of SOPs SOP identification for Standard Operating Procedures followed by the corresponding SOP code number, starting with 01 (a zero precedes the first nine SOPs); Followed by the letters EN for the English version; Followed by the number of the validated version starting with 01 (e.g.: SOP01EN01 for the first validated version). SOP01EN02_Development, Approval and Review of SOPs_08Oct09 Page 4 of 9

5 4.3. Numbering change due to the amendment of a validated SOP: SOP identification for Standard Operating Procedures followed by the SOP code number starting with 01; Followed by the letters EN for the English version; Followed by the number of the next validated version, e.g. 02 (e.g.: SOP01EN02 for a second validated version). 5. Approval and Implementation of RI MUHC Human Research SOPs Each SOP, together with appendices and references, should be submitted to the Associate Director of Clinical Research, RI MUHC for review and approval according to the SOP approval process. Appendix 1: Request for Approval of SOP will be used to complete this assignment Approval of each SOP and appendices is confirmed by the dated signatures of members cited in the Appendix: Request for Approval of SOP. Implementation of the SOP is confirmed by the date the SOP is posted on the RI MUHC Website/Portal Following approval and implementation, the RI MUHC Research Officer will offer training in SOPs to the human research community. This training should be documented by the individuals trained, in the signed and dated form, Appendix 2: SOP Training Documentation; a copy of which is included in this SOP Following a change or amendment to a SOP, updated training will be offered by the RI MUHC Research Officer. 6. Management of RI MUHC Research SOPs The RI MUHC Research Officer keeps the original signed version of the section, Approval of SOP, of each SOP in use in the institution These versions should be stored and filed such that they can easily be consulted. All validated versions of the SOP, as well as all subsequent amendments or changes should be maintained in this file. 7. Annual Approval or Change of RI MUHC Research SOPs Every SOP should be reviewed and approved annually by the Associate Director of Clinical Research, RI MUHC and, if necessary, by members of the institution involved in the SOP approval process. Review can also take place as needed, if circumstances dictate. Appendix 1: Request for Approval of SOP is to be used for this purpose Any revision or change to the SOP requires a written request from the institution to the Associate Director of Clinical Research, RI MUHC for any change to a SOP using Appendix 1: Request for Approval of SOP. References ICH: International Conference on Harmonisation (ICH) Requirements for Registration of Pharmaceuticals, Harmonised Tripartite Guideline (Including E6: Guideline for Good Clinical Practice (GCP), May SOP01EN02_Development, Approval and Review of SOPs_08Oct09 Page 5 of 9

6 McGill: McGill University Policy on the Ethical Conduct of Research involving Human Subjects. Approved and amended by Senate and Board of Governors (last amendment dated June 5, 2007 Minute 16). Appendices Appendix 1 Request for Approval of RI MUHC Human Research SOP(s) Appendix 2 RI MUHC Human Research SOP Training Documentation Appendix 3 RI MUHC Human Research SOP Tasks Delegation or Assignment of Responsibilities Form SOP01EN02_Development, Approval and Review of SOPs_08Oct09 Page 6 of 9

7 APPENDIX 1 SOP01EN02 Request for Approval of RI MUHC Human Research SOP(s) SOP number(s): Appendix number(s): Date of last validated version of SOP(s): () Date of request submission: () Is there a French version? Yes No Is there an updated French version? Yes No Revision or Changes requested SOP approved by: (block letters) Signature: SOP approved by: (block letters) Signature: SOP approved by: (block letters) Signature: Approval of SOP(s) Title: Title: Title: Posted on the RI MUHC web by: (block letters) Reason for refusal: Refusal of SOP(s) Document refused by: (block letters) Signature: Title: Page 1/1 SOP01EN02_Development, Approval and Review of SOPs_08Oct09 Page 7 of 9

8 APPENDIX 2 SOP01EN02 RI MUHC Human Research SOP Training Documentation Subject: Trainer: (block letters) Duration of training session: Trainer s Signature: Title and Department Employee s Name (block letters) Signature Page of SOP01EN02_Development, Approval and Review of SOPs_08Oct09 Page 8 of 9

9 APPENDIX 3 SOP01EN01 RI MUHC Human Research SOP Task Delegation or Assignment of Responsibilities Form Type of tasks: A) Signature for SOP approvals D) Implementation and management of SOPs G) Other B) Review of SOPs for approval E) Training of human research community H) Other C) Notice to REB of SOPs in application F) Other I) Other Name (block letters) Title Signature Tasks Start date End date Example: Mr. X Research Center Director Xxxxxxxxxxxxxxxxxx A, B, C, D Jan 3 rd, 2006 Example: Mr. X Assistant to the Director Yyyyyyyyyyyyyyyyyyy B, C, D Jan 5 th, 2006 Name (block letters) Title Signature Tasks Start date End date Page of SOP01EN02_Development, Approval and Review of SOPs_08Oct09 Page 9 of 9