What would you do about violations of research protocol occurring during data collection?
Video Script
| Click to view in RealPlayer
| Click to view in Windows Media Player
A clinical trial is being conducted at a number of sites to test the efficacy of a new drug. Dr.Porter, the principal investigator, has written a research protocol for training staff who will be collecting lab data. However, due to an unusually high rate of staff attrition, not all staff replacements received adequate training in data collection and documentation. In addition, regularly scheduled site visits by investigators were not strictly adhered to. Preliminary analyses reveals inconsistencies in the recorded measurements among staff members both within and between sites. A possible explanation is that some staff may have deviated from the required collection procedures (a consequence of the quality of training). This breakdown in both quality assurance and quality control compromises a portion of the data. Dr.Porter must decide how to address the issue for the remainder of the data collection period as well as how to handle the data that has been collected up to this point. Taking the role of the researcher, decide to act on one of the following options:
|  | Discard all questionable data, use the remaining data, and retrain the staff.
|  | After retraining staff, return to the field and attempt to re-collect the necessary data.
|  | Depending on the nature of the error (random vs. systematic) either discard data or use a systematic correction on the data.