The Clinical File Room database tracks and reports on all aspects of the receiving, filing and retrieval of documents and other material related to clinical trials.  In order to track this information, three primary master files are established.

• Investigator Master - This table contains all the investigators and their relevant contact information
• Protocol Master - This table contains all protocol information such as protocol number, description and indication.
• Site Master - This table tracks the receipt of critical site documents such as the date the 1572 was signed, the IRB approval expiration date, and confidentiality agreement.

As documents are received from the clinical trial site, they are filed in pre numbered file cabinets in the file room. Documents are filed according to date received, investigator, document category, document description and file cabinet location. According to your SOP, certain pre-defined documents can also be scanned and linked. This provides the flexibility for either going to the file cabinet directly or retrieving the document on-line. 

The File Room database can be searched by multiple search arguments to find required documents and information. The search list can then be printed and the documents retrieved.

Reports and Customization

Several standard reports on inventory status, distribution and requisition are provided.  We understand that your clinical trial supply requirements may differ from the packaged application and we will work with you to insure that your requirements are met.

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