![Page 1: Document Management at a small CRO DATA ANALYSIS AND REPORTING MWNL, 26 October 2006](https://reader035.vdocument.in/reader035/viewer/2022072009/56649d8c5503460f94a73334/html5/thumbnails/1.jpg)
Document Managementat a small CRO
DATA ANALYSIS AND REPORTING
MWNL, 26 October 2006
![Page 2: Document Management at a small CRO DATA ANALYSIS AND REPORTING MWNL, 26 October 2006](https://reader035.vdocument.in/reader035/viewer/2022072009/56649d8c5503460f94a73334/html5/thumbnails/2.jpg)
Document Management Software
• Specific document management software system is not in place, because of:– costs; software is too expensive for small
companies, and– use of stand-alone PCs in home-based work
places.
MWNL, 26 October 2006
![Page 3: Document Management at a small CRO DATA ANALYSIS AND REPORTING MWNL, 26 October 2006](https://reader035.vdocument.in/reader035/viewer/2022072009/56649d8c5503460f94a73334/html5/thumbnails/3.jpg)
Current Situation
All study data is recorded, handled and stored in a way that allows accurate reporting, interpretation and verification:– At the start of a project a Sponsor contact will be
appointed at AUTHOR!;– The Sponsor contact will be responsible for document
management of that project;– A project number will be assigned according to pre-
defined naming conventions (in SOPs);– A pre-specified directory structure (in SOPs) will be
created for the new project.
MWNL, 26 October 2006
![Page 4: Document Management at a small CRO DATA ANALYSIS AND REPORTING MWNL, 26 October 2006](https://reader035.vdocument.in/reader035/viewer/2022072009/56649d8c5503460f94a73334/html5/thumbnails/4.jpg)
Standard Directory Structure
Medical Writing; Project x– GEN– DAT– DRAFT_to_QC– COMMENTS _FROM_QC– DRAFT1 – DRAFTx – FINAL– MISCEL– MAIL– WORK
MWNL, 26 October 2006
![Page 5: Document Management at a small CRO DATA ANALYSIS AND REPORTING MWNL, 26 October 2006](https://reader035.vdocument.in/reader035/viewer/2022072009/56649d8c5503460f94a73334/html5/thumbnails/5.jpg)
Standard Directory Structure (2)
Directory name Contents
GEN General and study-specific information, e.g., protocol, template, guidelines
DAT Original data (tables, listings, plots) received from the Sponsor or created internally at AUTHOR!
DRAFT_to_QC: Preliminary first (internal) draft version (draft 0.0) of the report submitted to QC at AUTHOR (before being sent to the Sponsor).
COMMENTS _FROM_QC:
QC checklist and comments resulting from the QC (scanned copy of the original print-out on which the QC was performed).
DRAFT1: First draft sent to the Sponsor after the comments from the internal QC were implemented, plus comments from the Sponsor on this first draft.
DRAFTx: Draft x sent to the Sponsor after the Sponsor’s comments were implemented, plus comments from the Sponsor on draft x.
MWNL, 26 October 2006
![Page 6: Document Management at a small CRO DATA ANALYSIS AND REPORTING MWNL, 26 October 2006](https://reader035.vdocument.in/reader035/viewer/2022072009/56649d8c5503460f94a73334/html5/thumbnails/6.jpg)
Standard Directory Structure (3)
Directory name Contents
FINAL Final version approved by the Sponsor plus official confirmation of the Sponsor that this version was considered ‘final’.
MISCEL Items that can logically not be stored in any of the other subdirectories.
MAIL Relevant e-mail messages.
WORK Document(s) that are in the process of creation
MWNL, 26 October 2006
![Page 7: Document Management at a small CRO DATA ANALYSIS AND REPORTING MWNL, 26 October 2006](https://reader035.vdocument.in/reader035/viewer/2022072009/56649d8c5503460f94a73334/html5/thumbnails/7.jpg)
Standard Directory Structure (4)
Data Analysis: similar directory structure with GEN, WORK, MAIL and MISCEL:
– GEN– INDAT– WORK– SAS– DAT– TAB– GRF– LIS– LOG– REQCH– PREV– MAIL– MISCEL
MWNL, 26 October 2006
![Page 8: Document Management at a small CRO DATA ANALYSIS AND REPORTING MWNL, 26 October 2006](https://reader035.vdocument.in/reader035/viewer/2022072009/56649d8c5503460f94a73334/html5/thumbnails/8.jpg)
System Maintenance
• Backups are performed daily on a hard disk or server (including parallel running hard disks).
• Incremental backup system is in place -> different versions can be retained if necessary.
• Each workplace uses at least two hard disks with backup files; one is located at the work place and one is placed in a safe deposit at a bank. Every month, these hard disks are exchanged.
MWNL, 26 October 2006
![Page 9: Document Management at a small CRO DATA ANALYSIS AND REPORTING MWNL, 26 October 2006](https://reader035.vdocument.in/reader035/viewer/2022072009/56649d8c5503460f94a73334/html5/thumbnails/9.jpg)
System Maintenance (2)
• Access to PCs is under password control and is limited to people who signed a privacy declaration (or fall under the responsibility of the person who signed such a declaration).
• Virus scan is in place (continuous scan on incoming
documents) and total scan of all documents is performed weekly.
• At finalization of a project all files within that project directory are set to ‘Read Only’ and are archived.
• IT expertise available
MWNL, 26 October 2006
![Page 10: Document Management at a small CRO DATA ANALYSIS AND REPORTING MWNL, 26 October 2006](https://reader035.vdocument.in/reader035/viewer/2022072009/56649d8c5503460f94a73334/html5/thumbnails/10.jpg)
Future
• Central server• Growth -> implementation of specific document
management software.
MWNL, 26 October 2006