1. 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

2. 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.

3. 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.

4. 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?

5. 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.

6. 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?

7. 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?

8. 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.

9. 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

10. 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

11. 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