title: Quality and completeness of data documentation in an investigator-initiated trial versus an industry-sponsored trial.
abstract: Literature on the quality and completeness of data and documentation in investigator-initiated research studies is scarce. We carried out a study to compare the quality of data and documentation in an investigator-initiated trial (IIT) with those in an industry-sponsored study. We retrospectively studied the archived data pertaining to 42 patients enrolled in two trials, 14 patients in an industry-sponsored study and 28 randomly selected patients from an IIT. Trial-related documents were examined and scored for the completeness of the acquisition of data and for storage as per a pre-formulated checklist. Weighted scores were given for each point on the checklist proportional to its relative importance in the data documentation process. A global score and sub-scores for specific modules were given for each subject. The scores in the two studies were compared using the Mann Whitney U test. The total score for general documents was similar in the IIT (14/14, 100%) and the sponsored study (24/25, 96%). The mean summary global score obtained for study-specific documents (maximum possible score, 32) in the IIT (27.1; 95% CI 26.4-27.8) was also not significantly different from that in the sponsored study (27.9; 95% CI 26.7-29.1; p=0.1291). Thus, investigator-initiated studies carried out by independent researchers in high-volume academic centres, even without active data monitoring and formal audits, appear to adhere to the high standards laid out in the International Conference on Harmonisation-Good Clinical Practices guidelines, ensuring accuracy and completeness in data documentation and archival.
authors: Seth GS Medical College and KEM Hospital, Parel, Mumbai 400 012. cspramesh@gmail.com.
authors: Soumil
authors: S
authors: Patwardhan
authors: Seth GS Medical College and KEM Hospital, Parel, Mumbai 400 012. cspramesh@gmail.com.
authors: Nithya
authors: N
authors: Gogtay
authors: Seth GS Medical College and KEM Hospital, Parel, Mumbai 400 012. cspramesh@gmail.com.
authors: Urmila
authors: U
authors: Thatte
authors: Department of Surgical Oncology, Tata Memorial Centre, Parel, Mumbai 400 012 INDIA Author for correspondence: C S Pramesh e-mail: cspramesh@gmail.com.
authors: C S
authors: CS
authors: Pramesh
mesh_terms: D057189:Checklist; D066264:Datasets as Topic / Q000592:standards*; D004282:Documentation / Q000592:standards*; D005378:Financial Support; D017408:Guidelines as Topic; D006801:Humans; D007194:India; D007221:Industry; D012106:Research / Q000592:standards*; D012108:Research Personnel / Q000592:standards; D058028:Research Report / Q000592:standards*; D035842:Research Subjects; D012189:Retrospective Studies; D018709:Statistics, Nonparametric; D014495:Universities