iv. Inspection of sponsor’s records and reports 21 CFR 812.145

The sponsor-investigator must allow FDA employees access to all records and reports at their request.  An investigator who has authority to grant access shall permit authorized FDA employees, at reasonable times and in a reasonable manner, to enter and inspect any establishment where devices are held (including any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records of results from use of devices are kept).  [21 CFR 812.145(a)].

An investigator shall permit authorized FDA employees, at reasonable times and in a reasonable manner, to inspect and copy all records relating to an investigation.  [21 CFR  812.145(b)].

An investigator shall permit authorized FDA employees to inspect and copy records that identify participants, upon notice that FDA has reason to suspect that adequate informed consent was not obtained, or that reports required to be submitted by the investigator to the sponsor or IRB have not been submitted or are incomplete, inaccurate, false, or misleading.  [21  CFR 812.145(c)].

As an investigator, the sponsor-investigator has all the responsibilities of investigators in any clinical trial.