Spreadsheet: 0c88df82-2b36-4e2e-968a-39f668613a76
Sheet: Sheet1

[NAME] | Unnamed: 1 | COMPLETED | N/A | COMMENTS
Notify all parties | Sponsor (If an FDA audit) | r | r
 | IRB | r | r
 | Sub-investigators | r | r
 | Pharmacy | r | r
 | Laboratories | r | r
 | Medical Records | r | r
 | Administration | r | r
 | Legal Counsel | r | r
 | Reserve workspace for the auditor | r | r
General Overview | Prepare a general overview of the study | r | r
 | List all personnel and responsibilities delegated | r | r
List of subjects | List all subjects enrolled including name, address, and/or phone number, date enrolled, and completed, medical record number (to be kept as a reference for site research staff) | r | r
 | List of all subjects screened | r | r
II.  FILES MANAGEMENT |  | COMPLETED |  | COMMENTS
Organize all regulatory files by general heading in chronological order | Protocol (all versions) | r | r
 | Investigator’s Brochure (all versions) | r | r
 | Protocol Amendments | r | r
 | Form FDA 1572 (all versions) | r | r
 | CVs for PI and sub-investigators listed on all versions of the Form FDA 1572 | r | r
II.  FILES MANAGEMENT |  | COMPLETED |  | COMMENTS
[NAME] | Approved Letter (initial) for initial protocol with original consent form | r | r
 | Amendment approval(s) with approved informed consent forms (if applicable) | r | r
 | Informed consent forms (originals) for enrolled subjects | r | r
 | Informed consent forms (originals) for all screened subjects. | r | r
 | Status reports for:
 | q Yearly renewal(s) | r | r
 | q Adverse events | r | r
 | q Deaths
 | q Study termination
 | q Final summary
Communication | Sponsor correspondence | r | r
 |  | r | r
 |  | r | r
 |  | r | r
 | CRO correspondence | r | r
 |  | r | r
 |  | r | r
 |  | r | r
 | IRB correspondence | r | r
 |  | r | r
 | Monitoring Log | r | r
Laboratory | ____________Lab certification and normal ranges | r | r
 | ____________Lab certification and normal ranges | r | r
II.  FILES MANAGEMENT |  | COMPLETED |  | COMMENTS
Laboratory | ____________Lab certification and normal ranges | r | r
 | ____________Lab certification and normal ranges | r | r
Drug Accountability | Drug log including: | r | r
 | q Receipt of drug
 | q Dispensing
 | q Return
Device Accountability | Device log including: | r | r
 | q Receipt of device
 | q Dispensing
 | q Return
Equipment Accountability | Equipment log including: | r | r
 | q Receipt of equipment
 | q Dispensing
 | q Return
Subject Selection | Completed CRFs for each subject enrolled | r | r
 | Source documents for each subject enrolled | r | r
III.  REVIEW |  | COMPLETED |  | COMMENTS
Collect and review for each subject enrolled | CRFs completed for each subject enrolled | r | r
 | Source documents for each subject enrolled that documents the following: | r | r
 | q Condition of subject at time of entry into the study (Inclusion/Exclusion met)
 | q Case history documents Informed consent process was charted and obtained prior to start of study procedures
 | q Exposure to test article
 | [NAME] medication
III.  REVIEW |  | COMPLETED |  | COMMENTS
 | q Clinical assessments of the subject during the course of the study
 | q Laboratory reports
 | q Diagnostic tests
 | q Dose modifications
 | q Adverse events/death
 | q Protocol exemptions
 | q Early termination
IV.  Site Specific |  | COMPLETED |  | COMMENTS
Temperature logs | q Refrigeration | r | r
 | q Drug | r | r
 | q Name of item goes here | r | r
 | q Name of item goes here | r | r
Equipment | Name of item goes here
 | q Calibration logs | r | r
 | q Inspection reports | r | r
 | q Permits | r | r
 | q Licensure | r | r
 | Name of item goes here
 | q Calibration logs | r | r
 | q Inspection reports | r | r
 | q Permits | r | r
 | q Licensure | r | r
IV.  SITE SPECIFIC |  | COMPLETED |  | COMMENTS
 | Name of item goes here
 | q Calibration logs | r | r
 | q Inspection reports | r | r
 | q Permits | r | r
 | q Licensure | r | r
 | Name of item goes here
 | q Calibration logs | r | r
 | q Inspection reports | r | r
 | q Permits | r | r
 | q Licensure | r | r
 | Name of item goes here
 | q Calibration logs | r | r
 | q Inspection reports | r | r
 | q Permits | r | r
 | q Licensure | r | r
 | Name of item goes here
 | q Calibration logs | r | r
 | q Inspection reports | r | r
 | q Permits | r | r
 | q Licensure | r | r