An electronic regulatory document management system for a clinical trial network.
A computerized regulatory document management system has been developed as a module in a comprehensive Clinical Trial Management System (CTMS) designed for an NIH-funded clinical trial network in order to more efficiently manage and track regulatory compliance. Within the network, several institutions and investigators are involved in multiple trials, and each trial has regulatory document requirements. Some of these documents are trial specific while others apply across multiple trials. The latter causes a possible redundancy in document collection and management. To address these and other related challenges, a central regulatory document management system was designed. This manuscript shares the design of the system as well as examples of it use in current studies.
Department of Biostatistics, Bioinformatics and Epidemiology, Medical University of South Carolina, Charleston, SC, USA.
Wenle
W
Zhao
Valerie
V
Durkalski
Keith
K
Pauls
Catherine
C
Dillon
Jaemyung
J
Kim
Deneil
D
Kolk
Robert
R
Silbergleit
Valerie
V
Stevenson
Yuko
Y
Palesch
D000927:Anticonvulsants / Q000008:administration & dosage; D002544:Cerebral Infarction / Q000628:therapy; D026661:Clinical Trials Data Monitoring Committees; D003625:Data Collection; D003628:Database Management Systems; D004282:Documentation; D004311:Double-Blind Method; D001330:Electronic Data Processing; D006801:Humans; D020407:Internet; D008140:Lorazepam / Q000008:administration & dosage; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D012709:Serum Albumin / Q000008:administration & dosage; D013226:Status Epilepticus / Q000628:therapy
D000927:Anticonvulsants; D012709:Serum Albumin; D008140:Lorazepam