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 Sponsor and the Investigator’s files will be reviewed as part of the ongoing study monitoring. Financial disclosure is not subject to regulatory inspection and should be kept separately. Additionally, the Investigator must keep study records and source documents until the Sponsor provides written approval for their destruction. If the Investigator retires, relocates, or for any other reason withdraws from responsibility of keeping the study records, the Sponsor must be notified and suitable arrangements made for retention of study records and source documents needed to comply with national and international regulations (generally 2 years after discontinuing clinical development or after the last marketing approval).

Regulatory Documentation and Records Retention. The Investigator investigator is required to maintain up-to-date, complete regulatory documentation as indicated by the Sponsor sponsor and the Investigatorinvestigator’s files will be reviewed as part of the ongoing study monitoring. Financial disclosure is not subject to regulatory inspection and should be kept separately. Additionally, the Investigator investigator must keep study records and source documents until the Sponsor sponsor provides written approval for their destruction. If the Investigator investigator retires, relocates, or for any other reason withdraws from responsibility of keeping the study records, the Sponsor sponsor must be notified and suitable arrangements made for retention of study records and source documents needed to comply with national and international regulations (generally 2 years after discontinuing clinical development or after the last marketing approval).

Regulatory Documentation and Records Retention. The Investigator is required to maintain up-to-date, complete regulatory documentation as indicated by the Sponsor and the Investigator’s files will be reviewed as part of the ongoing study monitoring. Financial disclosure is not subject to regulatory inspection and should be kept separately. separately.‌‌‌ Additionally, the Investigator must keep study records and source documents until the Sponsor provides written approval for their destruction. If the Investigator retires, relocates, or for any other reason withdraws from responsibility of keeping the study records, the Sponsor must be notified and suitable arrangements made for retention of study records and source documents needed to comply with national and international regulations (generally 2 years after discontinuing clinical development or after the last marketing approval).

Regulatory Documentation and Records Retention. The Investigator is required to maintain up-to-date, complete regulatory documentation as indicated by the Sponsor and the Investigator’s files will be reviewed as part of the ongoing study monitoring. Financial disclosure information is not subject to regulatory inspection and should be kept separately. Additionally, the Investigator must keep study records and source documents until the Sponsor provides written approval for their destruction. If the Investigator retires, relocates, or for any other reason withdraws from responsibility of keeping the study records, the Sponsor must be notified and suitable arrangements made for retention of study records and source documents needed to comply with national and international regulations (generally 2 years after discontinuing clinical development or after the last latest marketing approval).