Industry: Pharmaceutical
Function: Customer Support
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| Biometric/Clinical CRF consensus (25%) | • Manager is satisfied that a satisfactory level of agreement was achieved among the members of the CRF development group before proceeding to the next stage of development.
• Consensus was achieved within the established production schedule. |
| CRF development (25%) | • Draft and revisions are completed before proceeding to the next stage of development and within the established production schedule. |
| CRF approval (25%) | • Manager is satisfied that the routing and final revisions are done quickly and thoroughly.
• CRF arrives at the printer on schedule. |
| Finished CRF study binder (10%) | • Co-workers are satisfied that:
• The camera-ready originals are clean and properly numbered. • Clear, instructional compile copy. • Sufficient binders were made available. • Printing instructions are clearly written and cover all aspects of production. |
| Organized, up-to-date master forms (10%) | • Form revisions are done prior to the next meeting.
• Revisions are done according to standard department norms. • The master form collection is organized and up-to-date. • Copies of revised master forms are replaced in the file cabinet prior to the next meeting. |
| Archived files (3%) | • The records administrator is satisfied that:
• The boxes are properly packed. • RTM forms contain the necessary information for accurate retrieval. |
| Annotated CRFs (2%) | • Annotated CRFs are produced within the required time frame. |
Customer Diagram: Documentation Specialist