Common use of Regulatory Documentation and Records Retention Clause in Contracts

Regulatory Documentation and Records Retention. The investigator is required to maintain up-to-date, complete regulatory documentation as indicated by the study sponsor and the investigator’s files will be reviewed as part of the ongoing study monitoring. Financial information is to be kept separately. Additionally, the investigator must keep study records and source documents consistent with the terms of the clinical study agreement with the study sponsor. If the investigator retires, relocates, or for any other reason withdraws from responsibility of keeping the study records, then the study sponsor must be notified and suitable arrangements made for retention of study records and source documents needed to comply with national and international regulations.

Regulatory Documentation and Records Retention. The investigator Investigator is required to maintain up-to-date, complete regulatory documentation as indicated by the study sponsor Study Sponsor and the investigatorInvestigator’s files will be reviewed as part of the ongoing study monitoring. Financial information is to be kept separately. Additionally, the investigator Investigator must keep study records and source documents consistent with the terms of the clinical study agreement with the study sponsorStudy Sponsor. If the investigator Investigator retires, relocates, or for any other reason withdraws from responsibility of keeping the study records, then the study sponsor Study Sponsor must be notified and suitable arrangements made for retention of study records and source documents needed to comply with national and international regulations.

Regulatory Documentation and Records Retention. The investigator Investigator is required to maintain up-to-date, complete regulatory documentation as indicated by the study sponsor Study Sponsor and the investigatorInvestigator’s files will be reviewed as part of the ongoing study monitoring. Financial information is to be kept separately. Additionally, the investigator Investigator must keep study records and source documents consistent with the terms of the clinical study agreement with the study sponsorStudy Sponsor. If the investigator Investigator retires, relocates, or for any other reason withdraws from responsibility of keeping the study records, then the study sponsor Study Sponsor must be notified and suitable arrangements made for retention of study records and source documents needed to comply with national and international regulations.regulations.‌‌