Benjamin Pryce, MD
Sacred Heart Hospital
22nd Street STE 204
Long Island City, New York 11104
The following letter is for the purpose of documenting and reviewing the observations made in the course of the routine half-yearly site check-up visit to the site. During the brief visit, a few personnel (CRC, regulatory etc.) were present to attend to my requirements.
The method of enrollment was carried out as per the guidelines. Prior to the process of screening, informed consent was given by the participants. No noticeable violations of protocol were detected. Effects of any unanticipated devices or adverse events were negligible. Records were kept in order. Regulatory files were reviewed as per traditional norms.
Queries were effectively resolved through the distribution of clarification forms to gather data. Facilities are sufficient. Reports seem to have been submitted to the IRB and have met with their approval.
The subsequent monitoring visit is scheduled for 12:15 pm on 17/03/2012.
I look forward to visiting the site again on the next scheduled date. If any questions arise regarding the content of this letter, give me a call at 8809784. Follow-up items of action may be addressed to the following address:
11/4 Colorado Boulevard
Little Fork, Colorado 11218
Clinical Research Associate.