Between Visits

The CRMs should remain in contact with investigators and supporting laboratories between visits so as to be aware of any or all of the following:

• Staff turnover

• Changes in investigator's other responsibilities

• Changes in facilities

• Patient deaths or severe adverse reactions

• Protocol deviations

• Cost overruns

• Loss of interest

Staff Turnover. In the event of excessive staff turnover, be prepared to provide supporting staff and to train new personnel.

Changes in Responsibilities. One reason for ongoing contact with investigators and their staff is try to head off diversions of the investigator's time. In that event you may have to monitor the investigator's activities more closely and revise downward your estimate of the number of patients likely to be treated at that site.

Changes in Facilities. Changes in facilities range from construction that forces patients to wait in the hall to out-of-alignment measuring devices to data entry terminals that have been unplugged. Working together, the CRM and the site coordinator can often resolve many of the resulting problems. For example, while screaming at a hospital administrator will not generate more space in an already crowded institution, direct contact with study subjects who have been inconvenienced can be used to motivate them to remain with the study.

Occasionally, a monitor is confronted with a series of handwritten data entry forms and is told that the computer has been down for a week or two. Too late to ask, "Why wasn't I informed?" The solution lies with training, with encouraging the investigator's staff to contact your staff if there are further problems and, not least, with following through on such contacts.

Patient Deaths or Severe Reactions. In the event of patient deaths or severe reactions, the investigator will often want to crack the treatment code. She should be discouraged from doing so until the medical monitor has had the opportunity for a thorough review of the case.

Deviations from Protocol. Deviations from protocol including modification of treatment without notification cannot be allowed to go undetected or unremarked. Immediate face-to-face contact by the medical monitor with the offending investigator is called for. Listening is always more effective than telling, but, inevitably, agreement to future adherence must be reached or the investigator's services terminated.

Loss of Interest. Loss of interest is not infrequent in long-term studies. A variety of methods for handling the problem are considered in the final section of this chapter. I strongly urge the production and distribution of a newsletter reporting on the trials at between two- and three-month intervals as an inexpensive method for both maintaining interest and disseminating information.

Cost Overruns. Depending on the type of billing arrangements, either you or the investigator may first realize that expenses at the investigator's site are excessive. The CRM's responsibility is to document all the expenses involved and be in a position to compare them with expenses at other sites. If it is the investigator who feels


Several years ago I was called in as a consultant by a medical-device firm, ostensibly to do a survival analysis requested by a federal agency, but in actuality (the almost invariable case when a consultant is brought in), to be the bearer of bad news concerning the many failed aspects of the study. The data management system crashed regularly. The database was filled with discrepancies, and there were no procedures in place for remedying them. As I proceeded step by step with the analysis, the 300 case report forms that had been filed so promisingly at the beginning of the study were reduced to 75 when I looked at the follow-ups. Five of the missing forms could be found on the CRM's desk—the rest simply had never been submitted (and, in some instances, never completed) by the physician.

You'd think the cardiologists would have wanted their money. They'd done the work; all they had to do was return the forms and the dollars would follow. "They've already been paid," was the unexpected response to my query. "Most are friends of the president of our company, he's a physician, too, and he made sure they were paid promptly." "Without checking to see if they'd done the work?" "Without checking." As it turns out, this company's device did increase the survival rate of the cardiac patients who were fortunate enough to receive it. But it took the company another year before sufficient data were on hand to validate their claim, and another year of deferred profits (and wasted lives) before their product could be brought to market.

aggrieved, the CRM (and the medical monitor) must listen and respond to the investigator's feelings.

The possible actions you as project manager might take are discussed under budgeting in the next chapter. Because of the monitors' continuing need to maintain rapport with investigators, I recommend that a third party be the one dispatched to work with the investigator if corrective action is called for.

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