Quality Assurance Audit

• SRC Study Number:

• Study Title:

• Study Director:

• Sponsor:

• Type of Audit: Critical Phase

• Audit Performed by:

• Conducted on

  Date

• Study Director Signature

  Sign

• QA Officer Signature (Final Review)

  Sign

• Management Signature (Indicates all comments addressed)

  Sign

• Procedures and Personnel Observed

General

• Protocol is signed and available to study personnel

  Yes

  No

  Not Applicable

• Protocol amendments, if any, are available to study personnel

  Yes

  No

  Not Applicable

• SOP's are available to study personnel

  Yes

  No

  Not Applicable

• SOP's exist for procedures performed

  Yes

  No

  Not Applicable

• SOP's accurately reflect the procedures

  Yes

  No

  Not Applicable

• Deviations from SOP's are documented

  Yes

  No

  Not Applicable

• Work areas are clean, neat, and well organized

  Yes

  No

  Not Applicable

• Reagents/solutions are properly labeled

  Yes

  No

  Not Applicable

• Training records for observed personnel are up-to-date and show proper qualifications for the performed procedures

  Yes

  No

  Not Applicable

Procedures

• Procedures performed as specified in the study protocol and/or SOP's

  Yes

  No

  Not Applicable

Equipment

• Automatic, mechanical, or electronic equipment is properly calibrated/standardized

  Yes

  No

  Not Applicable

• Equipment calibration/standardization is documented

  Yes

  No

  Not Applicable

• Equipment log books are available and up-to-date

  Yes

  No

  Not Applicable

• SOP's are available for each piece of equipment used

  Yes

  No

  Not Applicable

Test Systems

• Test system is identified by study number on cage/pen or temporary housing (i.e. carrier)

  Yes

  No

  Not Applicable

• Animals are uniquely identified

  Yes

  No

  Not Applicable

• Animal rooms are clean and daily records are up-to-date

  Yes

  No

  Not Applicable

• If multiple studies are housed in the same area, appropriate separation is maintained between studies

  Yes

  No

  Not Applicable

Test/Control Articles

• Dose administration is performed per protocol and/or SOP's

  Yes

  No

  Not Applicable

• There is appropriate documentation of reciept, storage, and use of test and control articles

  Yes

  No

  Not Applicable

• Test and control articles are clearly identified using:

• Name, CAS, or code number

  Yes

  No

  Not Applicable

• Lot or batch numbers

  Yes

  No

  Not Applicable

• Expiration date, if known or available

  Yes

  No

  Not Applicable

• Study Identification

  Yes

  No

  Not Applicable

• Storage Conditions

  Yes

  No

  Not Applicable

• Test and control articles are stored properly

  Yes

  No

  Not Applicable

Specimens (Samples and Sampling)

• Specimens are collected/obtained per protocol and/or SOP's

  Yes

  No

  Not Applicable

• Each specimen is clearly identified using:

• Test system

  Yes

  No

  Not Applicable

• Study Number

  Yes

  No

  Not Applicable

• Specimen type (matrix)

  Yes

  No

  Not Applicable

• Date of collection

  Yes

  No

  Not Applicable

• Time-point, if applicable

  Yes

  No

  Not Applicable

• Specimens are stored properly

  Yes

  No

  Not Applicable

Recording and Access to Data

• Hand generated raw data are recorded:

• Promptly, directly, legibly

  Yes

  No

  Not Applicable

• In indelible ink

  Yes

  No

  Not Applicable

• On appropriate forms

  Yes

  No

  Not Applicable

• Entries are dated and initialed

  Yes

  No

  Not Applicable

• Corrections to date entries do not obscure the original entry

  Yes

  No

  Not Applicable

• Corrections are justified/explained, dated and initialed

  Yes

  No

  Not Applicable

• If needed, raw data are organized and easily accessible

  Yes

  No

  Not Applicable

Findings

Finding

• Finding Response

• Audit Complete and provided electronically, via email, to Study Director and Management