Version 1 Date 20 Sep 2013

Checklist for monitoring site for DCGI accreditation

Facility
Organization chart including general information about the site, key personnel of the site, facilities, number of beds and lab, etc, names of investigators involved in clinical research with address, qualifications and contact number. Adequate space available for clinical research including a spacious room with lock and key facility with restricted entry, fire extinguisher and water hazard free. If site has no inpatient facility, any hospital attached in case of emergency? Hospital/clinic registration certificate, valid professional indemnity insurance, fire safety certification, biomedical waste-management license, narcotics license, radiology facility certification and other applicable certificates and licenses Third-party contracts and agreements with such as laboratories, waste management agency, emergency services, pest control, equipment maintenance, etc. Power backup facility for site List of clinical trials performed by each Investigator of the site with the following information Protocol number, protocol title, Name of Sponsor/CRO, study start date and completed date/ongoing status. List of delegated persons of the site including Sub I, CRC, phlebotomist, etc with their CVs and qualification/training certificates if any. CV and MRC of all PI, CO I, SUB I (At least one CO I for each study should be present) GCP training certificates of all delegated staff Facilities like computer, fax, photocopier,

Yes No Comments

Version 1 Date 20 Sep 2013 scanner, printer, telephone with ISD facility. Details of Institutional Ethics Committee including EC registration number, EC SOP with member list, frequency of EC meeting. In case the site does not have an IEC, verify whether following are in place: Statement of the investigator / institution that approval granted by another IEC would be abided by & statement from the approving IEC that they would take responsibility for ongoing supervision of the site. Name of local lab, with accreditation certificates or other quality inspection certificates. Sample collection, processing, and storage facilities including centrifuge, refrigerator, deep freezer (-20C freezer) etc with a temperature monitoring system. Reference ranges of each tests conducted at local laboratory. Facility for keeping lab kits at site including monitoring method for checking its expiry date. Site enrollment log of all ongoing studies. Site SOP with following sections 1, Informed Consent 2, Safety reporting and management 3,Delegation of responsibilities and training, 4, protocol compliance and protocol deviations 5, Clinical trial documentations 6, Record retention, archival, and destruction Facility of keeping medical record of patients mentions subject ID/ name /hospital registration number / and indication that subjects are participating in a clinical trial (MRD Department) Calibrated weighing scale; stadiometer (height measuring device) , thermometer; sphygmomanometer; 12-1ead ECG; centrifuge; crash-cart with emergency drugs and emergency-care facilities/equipment Facility for drug storage condition (lock and key facility) monitoring methods for temperature available? Facility for keeping used medication in the site

Version 1 Date 20 Sep 2013 Cupboards with lock and key facility for keeping subject files (access controlled) Is adequate space available at the site for retention of documents Facility for archiving documents properly for the period as specified and necessary measures have been taken for accidental and premature destruction like fire, pest control, water hazard etc