Need to get logo from Carol Development, Implementation and Maintenance of Serious Adverse Reconciliation Workflow and SOP For many of us, when we start a new position, all the necessary SOPs and other documentation is in place and available for use. When working at a young, growing company, this is not always the case. During this talk, I will present the development, implementation and ongoing maintenance of both a workflow and an SOP for AE/SAE reconciliation. Colleen Cox CareStat, Inc. Company logo here Need to get logo from Carol

Background Small department Scope and type of trials changing Role Definition Department of 6, 1 data entry person 1 clinical data coordinator 4 data managers Primarily focused on epidemology studies and device trials, now beginning three (count ‘em three) drug trials. Two in nephrology and one in oncology Role of data manager and data management department transitioning out of the IT department into the Biometric department. Lots of change and growth at the same time.

Existing SOPs SOPs newly approved Minimal forms Minimal work instructions SOPs had been approved within the previous quarter. An SOP for each of the basic data management functions. Tracking DE Validation Coding Work Instructions still being developed as in-house system in final phase of in-house development and validation. Forms for approval only, other forms not yet included, such as checklists and training documentation not included.

Initial Phase Review of existing SOPs Gap Analysis Nomenclature System Compatibility Workflow and Procedure Review Within the subsequent quarter, existing SOPs reviewed. Looking for completeness, consistency, both internal and external. External consistency included regulatory and the GCDMP. Nomenclature - DQF versus DCF. System Compatibility - can our system do what we say we are doing in the SOPS. Are there sections to be added or removed. Is the workflow efficient and effective? Does the procedure need to be revisited?

SOP Review Findings Nomenclature Workflow changes Gap in SAE Handling and Reconciliation Minor hiccups between the different SOPs Some workflow changes for streamlining purposes SAE handling and reconciliation not covered, new part of DM. SOP needs to be developed.

SOP Development Review regulations Review training materials Colleagues Industry Research GCDMP (version 2) Where to start? Review of applicable regulations Review of training materials (“Side of the road”) Discussions with colleagues (both internal and external) Research in industry journals, at trade shows, review of software systems Review of SAE reconciliation section of version 2 of the GCDMP. What to pull from where?

Hurdles Multiple Forms Different Content Different Handling Procedures Being a CRO, presents interesting and unique challenges. Not just one form, multiple forms single page form multiple page form (how to keep together) combined AE/SAE form How to handle follow up reports? Content of forms Basics the same Additional information differed more conmed complete, not relevant medical history Handling Procedures Process SAE report within the timeframe Process SAE report and narrative within the timeframe Where does reconciliation fit?

Work needs to begin Documentation in trial specific DMP Log of SAE discrepancies Interdepartmental meetings Provide support and clarification Section added to DMP template to ensure that documentation was complete what (CRF/fields) should be reconciled who should do reconciliation what should be reconciled data file report narrative? A log for SAE discrepancies was created to allow for tracking of all discrepancies (once identified). Interdepartmental meeting with the Safety group to clarify roles and responsibilities. Who is responsible for ensuring the receipt of a follow up report - if it is the report that needs to be corrected? Provide ongoing support (frustration venting) and clarification of reconciliation on an ongoing basis.

SOP Development Standard Sections Procedure Who When How With What Standard format easy to complete Procedure What should the DM do? What should the CDC do? How will the DM/CDC interact with Safety? Can we use our internal tracking system? Standard wording for queries What two items should be reconciled? Report/database file/database Data of record/database

SOP Review Internal review by department Review by Division management Review by SOP Committee Approval by Pres and Exec VP SOP goes through review process Drafted Initial review by author Review by department experience ideas/suggestions Review by divisional management Review by SOP Committee VPs and Operational Heads Clinical Project Direction Medical Affairs Review and Signoff

SOP Implementation Training Support Revisions Implementation Training session SOP Review of interdepartmental meeting minutes Sample Forms Review of Discrepancy Log Review of Log Reports Ongoing Project Support Review of Forms Review of DMP Assist with reconciliation Revisions Feedback from day to day What needs to be changed