Standard Operating Procedure Deliverable Preparation. March 15, 2012 Version 1.0

Transcription

1 Standard Operating Procedure Deliverable Preparation March 15, 2012 Version 1.0

2 Table of Contents Introduction SOP Training Roles and Responsibilities Deliverable Preparation Process Deliverable Preparation Process Flow Deliverable Preparation Process Description Draft Deliverable Draft Deliverable Preparation Draft Deliverable Review by MSOC Leadership and Submission to FDA COTR Draft Deliverable Review by FDA COTR Final Deliverable Final Deliverable Preparation Final Deliverable Review by MSOC Leadership and Submission to FDA COTR Final Deliverable Acceptance by FDA COTR Posting Deliverable Formatting Deliverable for Posting Approval of Formatted Deliverable by MSOC Leadership and Submission to FDA Sentinel Core Team for Review Approval of Formatted Deliverable for Posting by FDA Sentinel Core Team Authorization of Deliverable for Posting by MSOC Posting of Deliverable SOP - Deliverable Preparation March 15, 2012

3 Introduction Mini-Sentinel is a pilot project being conducted under contract with the U.S. Food and Drug Administration (FDA) to inform and facilitate development of a fully operational active surveillance system, the Sentinel System, for monitoring the safety of FDA-regulated medical products. Given Mini-Sentinel s large number of participating organizations, its interdependency across organizations and between core work streams, and its scale of surveillance activity, formal Standard Operating Procedures (SOPs) are needed to support the program. SOPs are detailed written procedures that establish bases for management control throughout Mini-Sentinel operations. Each SOP describes a process and provides instruction about how to perform that process by detailing key steps, roles and responsibilities, and decision making authorities. SOPs also provide the Mini-Sentinel Operations Center (MSOC) with bases for evaluating and improving processes. Purpose and Scope This SOP defines the Deliverable Preparation Process. Deliverables are final work products that fulfill contract requirements included in an FDA-issued Statement of Work. Deliverables may include, but are not limited to, scientific white papers, protocols developed for protocol-based assessments, reports from protocol-based assessments, and other project reports. Specific steps are delineated for preparation, review, revision, approval, and posting of Mini-Sentinel project deliverables. The SOP also indicates the individual or group responsible for each function. This SOP adheres to current Mini- Sentinel principles and policies as specified in the Mini-Sentinel statement of Principles and Policies. The Deliverable Preparation SOP will be implemented upon approval by the Mini-Sentinel Operations Center (MSOC) and the FDA s Contracting Officer s Technical Representative (COTR). Individuals affected by this SOP will be trained accordingly. The SOP will be revised as appropriate with the approval of the MSOC and the FDA. SOP Training All Process Participants whose work involves a particular SOP will be trained on that SOP within 30 days of 1) approval of the SOP or 2) initial engagement with a project for which the SOP is relevant. A schedule for training sessions will be provided by the SOP Manager. SOP - Deliverable Preparation March 15, 2012

4 Roles and Responsibilities Table 1 describes the roles and responsibilities associated with the Deliverable Preparation Process. Table 1: Deliverable Preparation Roles and Responsibilities Role Name Location General Responsibilities Specific Responsibilities FDA COTR and Sentinel Core Team MSOC Leadership Project Manager FDA MSOC MSOC Responsible for reviewing, accepting, and approving draft and final deliverables Responsible for overseeing preparation of draft and final deliverables and submitting them to FDA for review, acceptance, and approval Responsible for coordinating production of draft and final deliverables Review and comment on draft deliverable Accept final deliverable Approve deliverable (e.g., protocol, white paper) for posting on the Mini-Sentinel website** **Only done by Sentinel Core Team Participate in revising and editing deliverables (drafts and final), as appropriate Submit deliverables to FDA and back to Workgroup Leader as needed Send FDA-accepted deliverable to Webmaster for any additional formatting Authorize posting of FDA-approved deliverable Notify FDA of deliverable posting Ensure that Workgroup has necessary materials and resources to prepare deliverable Coordinates iterations of the draft deliverable between the Workgroup, MSOC, and/or FDA Ensure that all relevant project participants are engaged in the deliverable preparation process Webmaster MSOC Responsible for final document preparation and posting of final deliverable on MS website Workgroup Collaborators, MSOC, and/or FDA Responsible for preparing draft and final project deliverables Format FDA-accepted final deliverable in Mini-Sentinel deliverable template Verify compliance with Section 508 (accessibility of deliverable content) Post final deliverable on Mini-Sentinel website Prepare draft and final project deliverables SOP - Deliverable Preparation March 15, 2012

5 Deliverable Preparation Process The Deliverable preparation process provides procedures for managing the preparation, review, revision, approval, and posting of final project deliverables. All drafts, revisions and final deliverables will be sent via or secure portal as appropriate. Deliverable Preparation Process Flow The figure below depicts the Deliverable Preparation process. There are 6 roles in the process. Workgroup roles are in orange, MSOC roles are in green, and FDA roles are in purple. The workflow follows the numerical order illustrated. Figure 1: Deliverable Preparation Process Flow SOP - Deliverable Preparation March 15, 2012

6 Deliverable Preparation Process Description Process steps required for Deliverable Preparation are detailed below. Participating roles for each process step are indicated. 1 Draft Deliverable Prepare draft project deliverable, review and submit to FDA COTR for additional review. 1.1 Draft Deliverable Preparation Participating Role: Workgroup and Project Manager Timeline: As specified in the project-specific Scope of Work (SOW) or relevant contract language 1.1a: The Workgroup prepares a draft project deliverable in Microsoft Word under the supervision of the Workgroup leader(s) using the appropriate Mini-Sentinel template and submits the draft deliverable to the Project Manager for initial review by the MSOC Leadership. 1.1b: The Project Manager 1) ensures that Workgroup has the necessary materials and resources to prepare the deliverable, 2) oversees iterations of the draft deliverable between the Workgroup and the MSOC, 3) ensures that all relevant workgroup participants are engaged in the deliverable preparation process, and 4) submits for MSOC Leadership review. 1.2 Draft Deliverable Review by MSOC Leadership and Submission to FDA COTR Participating Role: MSOC Leadership Timeline: Within 2 weeks of receipt of the draft deliverable from the Workgroup MSOC Leadership performs the initial review of the draft deliverable. After deliverable has been approved by the MSOC Leadership, the deliverable is submitted to the FDA COTR via or secure portal. 1.3 Draft Deliverable Review by FDA COTR Participating Role: FDA COTR Timeline: Within two weeks of receipt of the draft deliverable from the MSOC 1 FDA COTR reviews the draft deliverable submitted by MSOC Leadership and returns it to the MSOC Leadership with comments and suggested revisions. 2 Final Deliverable Prepare final project deliverable, review and submit for FDA acceptance, and accept deliverable. 1 If it is anticipated that review will take longer than 2 weeks, FDA will notify MSOC Leadership prior to the due date. SOP - Deliverable Preparation March 15, 2012

7 2.1 Final Deliverable Preparation Participating Role: Workgroup and Project Manager Timeline: Within 2 weeks from receipt of the commented draft from MSOC 2 2.1a: The Workgroup revises the draft deliverable under the supervision of the Workgroup Leader(s). 2.1b: The Project Manager 1) ensures that the Workgroup has the necessary materials and resources to revise the deliverable, 2) if applicable, coordinates iterations of the draft deliverable, 3) ensures that all relevant workgroup participants are engaged in the deliverable revision process, and 4) ensures that the revised document displays tracked changes and incorporates both FDA comments and edits and the workgroup s revisions and responses. All revisions must be in MS Word track changes format using the commented draft received from FDA (step 1.2). Comments from FDA should remain in the document. All FDA comments must be addressed and a rationale provided in the comment box if no edits are made in response to a comment. Documents not revised with track changes will be returned. Two versions of the deliverable will be submitted to MSOC Leadership, one markup copy using MS Word track changes/comments and one clean copy without track changes. Workgroups should determine how to respond to FDA feedback based on the type of deliverable and the guidelines below: Scientific White papers or reports that are not specific to a safety signal assessment. All FDA comments must be addressed. The scientific discussion should adequately meet the needs of the FDA in terms of presentation of findings and any contextual information necessary for interpretation. Disagreements between the FDA and workgroups may be noted. Protocols developed for protocol-based assessments. While workgroups may not always be in agreement with the FDA perspective, the final protocol should reflect the scientific discussion and considerations that resulted in the development of a protocol that FDA intends to implement in order to inform regulatory decision making. A protocol should not be considered final until FDA intends to implement it as written. Protocols may require revisions based on data and methodological discussion during implementation. When revisions are necessary, the workgroup leader(s) shall provide these revisions within a change document template and adhere to the process outlined above for submission, review, and posting. 2 If it is anticipated that revision will take longer than 2 weeks, the Workgroup will notify the FDA COTR via the MSOC prior to the deadline and propose an alternative date. The workgroup will receive confirmation as to whether FDA will grant an extension as soon as possible after being notified. SOP - Deliverable Preparation March 15, 2012

8 Reports from protocol-based assessments. While workgroups may not always be in agreement with the FDA perspective, the final report should present the data and any necessary contextual information in a format that is useful to the FDA for interpretation of the findings. If the Workgroup chooses to provide any conclusions based on the findings of the assessment, the following statement should precede any discussion: The following is a discussion of the results of the Mini-Sentinel assessment of [insert topic]. However, this discussion does not take into account any other sources of information that the FDA may have available to inform a regulatory decision on this safety signal. Nor does it consider the larger public health impact of this medical product. The results of this assessment are intended to be used by the FDA in conjunction with other available information the FDA has to inform a regulatory decision (e.g., clinical development program, postmarket studies, and spontaneous reports). The Workgroup Leader(s) submits the draft final deliverable to the Project Manager for review by the MSOC Leadership. 2.2 Final Deliverable Review by MSOC Leadership and Submission to FDA COTR Participating Role: MSOC Leadership and Project Manager Timeline: Within 2 weeks of receipt of the draft-final deliverable from the Workgroup The Project Manager ensures that the draft-final deliverable displays tracked changes and incorporates FDA comments and edits as well as the workgroup s revisions and responses. MSOC Leadership and the Project Manager review and revise, as appropriate, the draft-final deliverable for consistency with standards as specified in the project-specific SOW or relevant contract language. MSOC Leadership submits both versions (clean and track change copies) of the draft final deliverable to FDA COTR for review and acceptance via or the secure portal. 2.3 Final Deliverable Acceptance by FDA COTR Participating Role: FDA COTR Timeline: Within 2 weeks of receipt of the final deliverable 1 FDA receives the final deliverable submitted by the Workgroup through the MSOC Leadership and accepts it as an official Mini-Sentinel work product. If the FDA COTR does not accept the final deliverable, return to Section 1.2 for the process for further revision. If there are revisions and/or comments remaining after the second revision, a conference call will be scheduled by the MSOC with the Workgroup Leader(s) and FDA COTR to identify and address any outstanding issues. 1 If it is anticipated that review will take longer than 2 weeks, FDA will notify MSOC Leadership prior to the due date. SOP - Deliverable Preparation March 15, 2012

9 3 Posting Deliverable Prepare project deliverable for posting on the Mini-Sentinel website ( submit to FDA for approval, authorize posting, and post. 3.1 Formatting Deliverable for Posting Participating Role: Webmaster and Project Manager Timeline: Within 2 weeks of receipt of the final deliverable The Webmaster and Project Manager, 1) proof the formatted deliverable, 2) review and revise if necessary to meet MSOC standards, 3) create a pdf version of the document, 4) check the pdf for compliance with Section 508 (adherence to accessibility standards), and 5) collaborate with the Workgroup to meet accessibility requirements, as necessary. 3.2 Approval of Formatted Deliverable by MSOC Leadership and Submission to FDA Sentinel Core Team for Review Participating Role: MSOC Timeline: Within 1 week of receipt of the final deliverable MSOC receives the formatted final deliverable from the Webmaster and notifies FDA Sentinel Core Team of impending posting. The MSOC provides the Sentinel Core Team with the final version of the deliverable and an anticipated posting date. 3.3 Approval of Formatted Deliverable for Posting by FDA Sentinel Core Team Participating Role: Sentinel Core Team Timeline: Within 1 week of receipt of the formatted deliverable from the MSOC Sentinel Core Team will review the formatted for posting deliverable and authorize the MSOC to post. If posting should be delayed for any reason, the Sentinel Core Team will provide notification to the MSOC. 3.4 Authorization of Deliverable for Posting by MSOC Participating Role: MSOC Timeline: Upon receipt of approval for posting by FDA s Sentinel Core Team MSOC authorizes the Webmaster to post the final deliverable on the Mini-Sentinel.org website. 3.5 Posting of Deliverable Participating Role: Webmaster Timeline: Within 1 week of authorization for posting by MSOC, or on the agreed upon posting date. The Webmaster and authorized MSOC personnel post the approved formatted final deliverable to the Mini-Sentinel website. The Webmaster and/or the authorized MSOC personnel will notify the Sentinel Core Team when deliverable has been posted. SOP - Deliverable Preparation March 15, 2012