STANDARD OPERATING PROCEDURE NO. CM

Transcription

1 STANDARD OPERATING PROCEDURE NO. CM Version date: Effective Date: Replaces SOP No.: 1 5 January February Approved by: Date

2 No: CM Effective Date: 15 February 2013 Version Date: 15 January 2013 CONTENTS: 1. DEFINITIONS/REFERENCES PURPOSE SCOPE RESPONSIBILITIES PROCEDURES Creation of Clinical Management Plan Review of Clinical Management Plan Approval of Clinical Management Plan Revision and amending of Clinical Management Plan RELATED SOPs and GUDELINES APPENDICES/FORMS/SUPPORTING DOCUMENTS Appendix 1 Main Procedural Differences from Previous Version Appendix 2 Clinical Management Plan template Version 15/01/2013 Page 1 of 7 Confidential

3 No: CM Effective Date: 15 February 2013 Version Date: 15 January DEFINITIONS/REFERENCES Clinical Management Plan: A plan developed by the Project Manager or designee that identifies the overall contractual tasks and responsibilities and the processes of how each of those tasks and responsibilities will be accomplished. This may include, but is not limited to identification of all team members and associated clinical and data operations responsibilities. 2. PURPOSE To describe the procedures for the development, review, and approval of the Clinical Management Plan 3. SCOPE This process applies to all projects where the creation of a Clinical Management Plan is identified as a contractual deliverable. The Project Manager is responsible for ensuring that the Clinical Management Plan is developed, but may delegate tasks to other team members, as appropriate. 4. RESPONSIBILITIES Project Manager or designee: Develops the Clinical Management Plan with designated team members. Obtains approval from the Line Manager and other designated reviewers. Maintains the Clinical Management Plan. Distributes and explains the Clinical Management Plan to appropriate clinical team members. Documents distribution of designated sections to the investigational site, as appropriate. Line Manager: Reviews and approves all versions of the Clinical Management Plan. Distributes applicable sections of the Clinical Management Plan to the Sponsor in accordance with the scope of work, and approves distribution of applicable sections to the investigational site and any designated third party. Quality Assurance Manager: may be requested to review and approve relevant sections of the Clinical Management Plan, as appropriate, to ensure compliance with the documented scope of work, applicable SOPs and project instructions. 5. PROCEDURES 5.1 Creation of Clinical Management Plan The Project Manager or designee is responsible to: 1. Develops and oversees process 2. Determines, in conjunction with the sponsor, the template to be used for the Clinical Management Plan 3. Defines timelines for the development and review of the Project Management Plan 4. Notifies reviewers of upcoming review 5. Ensures draft Clinical Management Plan is developed within the specified timeline 6. Versions document with version date and version number (v1, v2, v3 etc.) 7. Forwards draft to the reviewers, providing timeline for review Version 15/01/2013 Page 2 of 7 Confidential

4 No: CM Effective Date: 15 February 2013 Version Date: 15 January 2013 The Project Manager or designee has options for creating the Clinical Management Plan; use the sample template as provided in this SOP, or create new document, or use Sponsor template, or a combination of options that may be described in the contract, or at the request of the Sponsor. Following items must be clearly documented in the Clinical Management Plan: The clinical and related contractual obligations described in the scope of work, the budget including assumptions, and the transfer of regulatory obligations. Detailed information on the clinical activities to be performed, including the communication plan, budget and assumptions, time lines and Clinical staff resources necessary to perform these activities References to applicable SOPs and project instructions Management and monitoring of the progress of the project scope of work according to contractual obligations, protocol specifications, GCPs and applicable regulations, SOPs and project instructions including, but not limited to, documentation of the following activities Quality control of clinical deliverables Identification and communication of out-of-scope activities Project-specific training of clinical team members Information dissemination, including updates of key documents (e.g., Investigator s Brochure) Coordination of the study completion process, including transfer of files/data and archiving Appendices such as the Monitoring Plan, Data Management Plan, or Safety Monitoring Plan may be generated as separate documents, if required by Sponsor/contract. 5.2 Review of Clinical Management Plan Project Manager or designee and the Line Manager shall identify the appropriate reviewers for the Clinical Management Plan, including a designated Clinical reviewer other than the PM or LM, which may include Quality Assurance Manager, Regulatory Manager or any other qualified reviewer(s). 5.3 Approval of Clinical Management Plan Project Manager or designee will incorporate Clinical reviewer s comments if any and he will return revised version to Clinical reviewers for final review, as appropriate. After final review Clinical reviewers should sign the appropriate approval page on Clinical Management Plan as a sign that the document has been approved. After final review and approval Project Manager or designee will send approved Clinical Management Plan to Sponsor for review if required by Sponsor and to the assigned Clinical Research Associate(s) for filing. 5.4 Revision and amending of Clinical Management Plan The Clinical Management Plan should be periodically reviewed and updated as the clinical study progresses and/or procedures change or tasks are added to the clinical Version 15/01/2013 Page 3 of 7 Confidential

5 No: CM Effective Date: 15 February 2013 Version Date: 15 January 2013 component of the study. It is acceptable for an individual section(s) of the Clinical Management Plan to be updated and distributed, provided that the required reviews and distribution are documented. The Project Management Plan will be amended based on changes in the scope of work and associated changes in the clinical budget. All amendments will be approved by the Line Manager, the Quality Assurance Manager or designated Clinical reviewer and any other reviewer(s). All approved versions of the Clinical Management Plan will be distributed to the PM for filing in the Project Management File, to appropriate Clinical team members and filed in the Central Clinical Study Files 6. RELATED SOPs and GUDELINES/SUPPORTING DOCUMENTS SOP CM.1Feasibility 7. APPENDICES/FORMS Appendix 1 Main Procedural Differences from Previous Version Appendix 2 Clinical Management Plan template Version 15/01/2013 Page 4 of 7 Confidential

6 No: CM Effective Date: 15 February 2013 Version Date: 15 January 2013 APPENDIX 1 Version 15/01/2013 Page 5 of 7 Confidential

7 No: CM Effective Date: 15 February 2013 Version Date: 15 January 2013 MAIN PROCEDURAL DIFFERENCES FROM THE PREVIOUS VERSION SOP # MODIFICATION Version Date CM draft Version 15/01/2013 Page 6 of 7 Confidential

8 No: CM Effective Date: 15 February 2013 Version Date: 15 January 2013 APPENDIX 2 Version 15/01/2013 Page 7 of 7 Confidential

9 EFFECTIVE DATE: VERSION NO.: *If amended, see section 8 and record details of changes from previous version Project Name: Project Number: Protocol Number: Sponsor Name: Address: Telephone No.: Fax No.: PREPARED BY: Name/Title: Office/Address: Telephone No.: Fax No.: PROJECT MANAGER APPROVED BY: NAME: SIGNATURE: DATE: PROJECT TEAM LEADER NAME: SIGNATURE: DATE: QUALITY ASSURANCE REVIEW NAME: SIGNATURE: DATE: REGULATORY AFFAIRS REVIEW NAME: SIGNATURE: DATE: OTHER REVIEW (SPECIFY) DISTRIBUTION LIST: Page 1 of 9

10 Purpose: To establish and document practical working methods for the clinical team based upon the protocol, scope of work, and contract. To facilitate the exchange and documentation of relevant information and expectations between Altiora and the Sponsor (INSERT name of Sponsor), and where appropriate the Investigator Scope: This clinical management plan applies to the (INSERT project name/reference) from the time that Altiora assumed contractual responsibility for clinical trial management until those contractual obligations are completed. TABLE OF CONTENTS Page 2 of 9

11 1.0 CLINICAL PROJECT/ACTIVITIES DESCRIPTION 2.0 CLINICAL SCOPE OF WORK, RESPONSIBILITIES AND PROCEDURES 2.1 DESCRIPTION OF ACTIVITIES 2.2 SPONSOR OBLIGATIONS 2.3 TRANSFER OF REGULATORY OBLIGATIONS 3.0 CLINICAL PROJECT BUDGET AND ASSUMPTIONS 4.0 CLINICAL PROJECT TIMELINE 5.0 CLINICAL PROJECT TEAM 5.1 ALTIORA CLINICAL PROJECT TEAM 5.2 SPONSOR CLINICAL CONTACTS 5.3 SITE/THIRD PARTY CONTACTS 6.0 CLINICAL COMMUNICATIONS PLAN 6.1 COMMUNICATIONS WITH SPONSOR 6.2 INTERNAL CLINICAL TEAM COMMUNICATIONS 6.3 COMMUNICATIONS WITH STUDY SITES 7.0 QUALITY PLAN 8.0 AMENDMENTS TO THE PROJECT AND CLINICAL MANAGEMENT PLAN 9.0 ATTACHMENTS 1.0 CLINICAL PROJECT/ACTIVITIES DESCRIPTION Page 3 of 9

12 A brief description (1-2 sentences, checklist or bulleted list) of the broad scope of the study (for example, phas e of study, indication, multi-center trial, countries involved, etc). 2.0 CLINICAL PROJECT SCOPE OF WORK, RESPONSIBILITIES AND PROCEDURES Reference where the overall list of responsibilities and referenced SOPs can be located, or provide details below: CLINICAL AND RELATED TASK LIST RESPONSIBLE ORGANIZATION RELEVANT SOPs (LIST PROCEDURE NUMBERS)* (To be customized for project) Site Identification Site Selection Visits Investigator Selection Site Initiation Visits Investigator s Meeting Regulatory Document Collection Investigational Product Shipment Blinding/Unblinding Monitoring Visits Closure Visits Adverse Event Reporting Data Management *If Altiora is responsible for a task and non Altiora s procedures are to be followed, list Sponsor SOP numbers here and see section 9 Attachments 2.1 DESCRIPTION OF ACTIVITIES Page 4 of 9

13 Provide a more detailed description or specific reference for tasks listed in Table 2.0 (above). The goal is to completely and unambiguously specify the requirements and procedures to be followed for each. Specify if the referenced document is included as an attachment (see section 9.0). Indicate if a specific activity is To be added or Not applicable. SPECIFIC ACTIVITY DESCRIPTION/REFERENCE 1. List of assigned sites and responsible clinical study monitors (current versions) 2. Description of team member training to include: SOP specific training if Altiora SOPs will no be used. Project specific training, by whom and how often. Where documentation of this training will be maintained. 3. List of all approved study specific forms (not including approved standard forms) and their intended use. 4. Process of clarifications for protocol interpretation and CRF completion (as applicable to protocol) Sponsor definition for screen failures Randomization process Procedures for obtaining protocol clarification/authorization of exceptions Patient unblinding procedures Definition for visit windows Prohibited concomitant medications Frequency of required site activities and maintenance of study equipment 5. Site monitoring visits Can include reference to study specific monitor s manual Frequency of visits Duration of visits, when known How deviations from the anticipated monitoring schedule will be recorded and approved by Sponsor Project specific guidelines for site visit reports and follow-up letters Time frame and method for submission and review of site visit reports to the CTL or designate 6. Timing of CRF submission relative to site visits (for example, Who sends CRFs where/crf Shipment procedures, CRFs sent as completed or collected by monitors after review at site visit). If ecrf is not in use. Page 5 of 9

14 7. Instructions for protocol deviation tracking by site and across project 8. Immediately Reportable Adverse Event (IRAE) Procedures: (as applicable to protocol) Sponsor definition of IRAE Sponsor definition of pre-existing condition Sponsor definition of a planned hospital admission Describe procedures for reporting IRAEs, including timelines to be met and contact details for the staff/offices/departments involved 9. Source Document Verification Procedures: (as applicable to protocol and scope of work) Percentage of source document checking Identification of key variables, if percentage of source document checking is different for key and non-key variables 10. Query Generation and Resolution Frequency of query generation and cross checks to be performed by data management Procedures for resolution of data clarifications and the documentation and filing requirements for data clarifications Standard procedure for documenting authorization of site personnel (other than PI) to resolve (approve and sign) data queries 11. Method and frequency of communicating and transmitting site specific regulatory updates to clinical study monitors where applicable 12. Investigational Product: (as applicable to protocol and scope of work) Frequency of Investigational Product accountability/reconciliation Handling, and shipping instructions for Investigational Product Investigational Product blinding procedures, if applicable Investigational Product relabeling instructions, if applicable Investigational Product recall instructions 13. Handling and shipping instructions for central or local laboratories, as applicable 14. Status reporting guidelines: (as applicable to Page 6 of 9

15 protocol and scope of work) Instructions for Site Instructions for CRAs Status Reports to Sponsor 15. Central Clinical Study File/Investigator Site File Project specific Investigator Site File contents (Table of Contents) Project specific Central Clinical Study File contents (Table of Contents) Reference manual for sites (Table of Contents) Instructions for completion of study logs 16. Procedures for Study Closure Archiving Instructions 2.2 SPONSOR OBLIGATIONS Reference or list below the sponsor obligations, in particular any obligations which would affect Altiora ability to meet time scales and budgets. Due Date: Due Date: Due Date: 2.3 TRANSFER OF REGULATORY OBLIGATIONS Only complete this section if there are any specific regulatory responsibilities that the sponsor has transferred to Altiora. Or where applicable, include a copy of the Transfer of Regulatory Obligations. 3.0 CLINICAL PROJECT BUDGET Provide information regarding the project budget and assumptions (issues that may need to specified include: fixed price, time and materials, consulting project with upper limit, incentive or penalty clause(s), version date and status of contract, specific work codes to be used, etc.). Reference can be made to the current version of the budget and assumptions being followed (see Section 9.0 Attachments). 4.0 CLINICAL PROJECT TIME LINE Identify all Sponsor and Altiora deliverables (as a minimum). Reference can be made to a separate detailed project plan (see Section 9.0 Attachments). TASK/MILESTONE START DATE END DATE 5.0 CLINICAL PROJECT TEAM Page 7 of 9

16 Identify principal Altiora and Sponsor Project Team members only. Reference can be made to a separate detailed project team/contact list (see Section 9.0 Attachments). 5.1 ALTIORA CLINICAL PROJECT TEAM NAME/ OFFICE/ADDRESS TITLE/ROLE TELEPHONE FAX 5.2 SPONSOR CLINICAL CONTACTS NAME/ OFFICE/ADDRESS TITLE/ROLE TELEPHONE FAX 5.3 SITE/THIRD PARTY CONTACTS (including Central IRB, central laboratory, etc. as applicable) NAME/ OFFICE/ADDRESS TITLE/ROLE TELEPHONE FAX 6.0 CLINICAL COMMUNICATIONS PLAN 6.1 COMMUNICATIONS WITH SPONSOR Specify the regular communications with the Sponsor (for example, weekly teleconference, monthly progress report, quarterly meetings, etc.) 6.2 INTERNAL CLINICAL PROJECT TEAM COMMUNICATIONS Specify internal communication channels (for example, Project Management and reporting structure, status reports to be circulated, etc.) 6.3 CLINICAL STUDY MONITOR COMMUNICATIONS WITH STUDY SITES Specify the frequency and method(s) of communicating with the study sites and documentation requirements. Page 8 of 9

17 7.0 QUALITY PLAN List the primary measures, checks and reviews to be performed for specified clinical deliverables. Specify any checks and review activities that will be performed by the Sponsor. 8.0 AMENDMENTS TO THE PROJECT AND CLINICAL MANAGEMENT PLAN Provide a summary list of all amendments made to the Clinical Management Plan. For each Amendment/Version issued, identify the specific section(s) updated in that version. Clearly summarize the major changes to be implemented including the effective date of the change(s). 9.0 ATTACHMENTS TO THE CLINICAL MANAGEMENT PLAN REFERENCE VERSION DATE/NO. Page 9 of 9