A Remote Data Entry System for International Clinical Trials

Abstract

A major need in international clinical trials is to make available for analysis and submission to regulatory agencies large amounts of accurate data from diverse geographical locations “in a short amount of time. ”In the past, time has been controlled by the geographical distances involved; volume of data has been controlled by time; accuracy has been controlled by volume and time. In order to shorten the time period, increase the number of patients, and maintain higher levels of accuracy, Merck & Co Inc has designed a new data entry system based on remote data entry using Full-Screen Processing. This system facilitates the entry of data from any remote location, thus eliminating 90% of the time delay in using the postal service. Elimination of this mailing time results in more patients' data entering the system before the cutoff date. In the past, Merck has required that all Case Report Forms must be typed, because diverse handwriting idiosyncrasies have led to a higher error rate. With data entry and data coordination being conducted close to the source, it has been demonstrated that handwritten Case Report Forms (CRFs) can be handled with a high degree of accuracy. Once again, time has been gained for the entry of additional patients. Case Report Forms are printed from the system and proofread. Corrections can be made and individual pages reprinted. Final copies of the printed Case Report Forms are sent to the investigators for review and signature. Because the data which has been entered into the system is reviewed twice (by the proofreader and the investigator), the resulting accuracy rate is greatly increased. The many facets of this system can result in data-entry time savings from 1 to 3 months. The time saved can be used to speed up the delivery of a drug to the market, to increase the volume of patient data supporting a new drug application, and to allow more time for error-checking. A big plus in accuracy is the fact that the system database is used to print the Case Report Forms to be signed by the investigators, rather than creating a database from typed and signed Case Report Forms. In addition, remote data can be made available at the remote sites for analyses and publications, without resorting to duplicate data entry. At Merck, remote data entry is utilized along with older, centralized data entry systems. It is felt that no single system answers all needs, but that remote data entry can be the best answer in handling international data for clinical trials.