Late and Incomplete Forms

Late and incomplete forms are the major source of cost overruns and trial delays. They cannot be tolerated. Automated transfer of data simplifies the preparation of a summary report detailing the forms received and the date of the next form due by site and patient ID. This report should be updated and reviewed daily by the CRM. Overdue and incomplete forms should be flagged as in Table 14.1. The standard procedure for dealing with delays is as follows:

1. The CRM places a telephone call to the site coordinator to determine the source of the difficulty.

2. She does what she can to facilitate collection and transmission of the needed information.

3. If the missing data involve several patients at the same site, she may choose to visit the site or to refer the matter to the medical monitor.

4. In turn, the medical monitor may either deal with the problem(s) or refer them to the project manager.

5. The primary responsibility of the project manager is to ensure that procedures are in place and that decisions are made not deferred.

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