336 Abstracts

• a REQUEST FORM used by the Clinical Operations, Regulatory Affairs and Biometry Depart- ments to collect all parameters for the randomization;

• a VAX/VMS COMMAND PROCEDURE to produce a control file used by the system; and • SAS-BASED PROGRAMS using the control file.

The SAS programs produce: • randomization of patient numbers; • documentation of the randomization; • selection of a subset of patient numbers for packing; • labels for packaging the drug; • inventory lists of packaged d r u g s

The presentation describes: • the use and contents of the randomization request form; • the VMS and SAS codes used in the system; • the system's ability to randomize stratified, multiple dose, and crossover design as well as

flexibility in defining block sizes. An example randomization will be presented with completed forms, file descriptions and

computer output from the sys tem

Computerized Follow-Up Program for Large Clinical Trials Sylvie A h n , C h r i s t i a n van Eyll, V e r o n i q u e H e r i m a n , E l izabe th O ' D o h e r t y , Isabel le Mot t a rd , M a g d a l e n a Delgadi l lo University of Louvain, Brussels, Belgium (P-02) Large trials imply the collection of information over a long period of time and with narrow time windows for each visit. As many patients are at different stages of the protocol and as several trials may be ongoing in parallel, an "help-system v is required to track the information. For that purpose, a program has been developed in our institution and has been used since 1984 to follow more than 1000 patients in trials of heart failure and angina pectoris. The program, written in Fortran 77, is implemented on a HP A900 computer. For each study, the sequence of visits or phone calls and of the data to be gathered are entered into the program. Once a patient is recruited, his (her) name and all pertinent information are filed in the computer. The patient is then automatically scheduled for all future visits. By consulting the program daily, one receives a listing of patients to be controlled as well as the type of information needed. Missing data are "flagged" and continuously recalled until adequate information is provided. Outputs of programs also include personalized letter to the patients or their physicians, listing of completed or missing data.

(P-03) Poster Withdrawn

Adverse Drug Reactions in Clinical Trials Phi l ip Day, Clair H a a k e n s o n , C i n d y Coil ing, Carol Frye VA Cooperative Studies Program, Albuequerque, New Mexico (P-04) ADRs (adverse drug reactions) in clinical trials present ethical and legal issues in addition to the purely statistical concerns of data collection and management. For safety reasons, protocols must make provisions for prompt and appropriate treatment of the patient. To protect other patients, FDA regulations require specific procedures to report, evaluate and disseminate alarming new information. ADRs are of particular concern to the VA CSP (Veterans Administration Cooperative Studies Program) because most of its protocols involve drugs. The CSP has developed a package of forms and procedures to uniformly handle ADRs in its drug trials. Two levels of responsibility for dealing with ADRs are addressed: the investigator level and the study management level. Investigators receive specialized forms, criteria and instructions for reporting alarming reactions, promptly to study management. Provisions for emergency code breaks are also included. Study management consists of the chairman (M.D.), a statistician and a pharmacist. These individuals evaluate all reports received and apply CSP criteria to determine if immediate notification of all investigators, the FDA and DMB (Data Monitoring Board) is required. Procedures are consistent with FDA requirements and are applied to all CSP trials. This system for reporting, evaluating and following-up on ADRs have proven effective in meeting the ethical, regulatory and statistical needs of clinical trials in the CSP.