document management at a small cro data analysis and reporting mwnl, 26 october 2006

Document Managementat a small CRO

DATA ANALYSIS AND REPORTING

MWNL, 26 October 2006

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.


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.


Standard Directory Structure

Medical Writing; Project x– GEN– DAT– DRAFT_to_QC– COMMENTS _FROM_QC– DRAFT1 – DRAFTx – FINAL– MISCEL– MAIL– WORK


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.



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



Data Analysis: similar directory structure with GEN, WORK, MAIL and MISCEL:

– GEN– INDAT– WORK– SAS– DAT– TAB– GRF– LIS– LOG– REQCH– PREV– MAIL– MISCEL


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.


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


Future

• Central server• Growth -> implementation of specific document

management software.


document management at a small cro data analysis and reporting mwnl, 26 october 2006

Documents