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 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 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.
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. 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. At expiration of the retention period of the records, the sponsor will notify the study sites thereof.
Regulatory Documentation and Records Retention. Essential documents must be retained by the investigator in compliance with the medical device directive and its local transposition as well as other applicable national and international regulations. The investigator(s)/institution(s) must comply with record retention stipulations outlined in the Clinical Study Agreement. Additionally the Investigator will be supplied with further instruction at study completion.
