Appendix A: Investigator Site Audit Checklist

Appendix A: Investigator Site Audit Checklist

STUDY PERSONNEL
Designation / Name / Tick if Present
Investigator:
Co-investigator 1:
Co-investigator 2:
Other (specify)
STUDY PROTOCOL
Final Protocol present? / Yes / No
Date of Final Protocol: / d / d / m / m / y / y
Yes / No
Sponsor’s signature present on Final Protocol?
Yes / No
Investigator’s signature on Final Protocol?
Date of Investigator’s Signature: / d / d / m / m / y / y
Yes / No
Has the study protocol been translated?
Yes / No
Has the translation been reviewed/approved by EC?
Protocol Amendments and/or Modifications
Yes / No
Are there any protocol amendments?
Date of protocol amendment: / d / d / m / m / y / y
Date of protocol amendment: / d / d / m / M / y / y
Yes / No
Are protocol amendments present at site?
Yes / No
Is Investigator’s signature on Protocol amendments?
Date Signed by Investigator: / d / d / m / m / y / y
Yes / No
Do amendments or modifications to the protocol require any changes to the Informed Consent documentation? If yes, provide details below:

______

Yes / No
Financial/Study Agreement present?
Yes / No
Has it been signed by the Investigator?
Date signed by Investigator: / d / d / m / m / y / y
Notes:

______

INVESTIGATOR BROCHURE (IB)
Yes / No
IB or equivalent document present?
Yes / No
Is the IB or equivalent document current/revised?
Date of IB or equivalent document / d / d / m / m / y / y
Yes / No
Is the IB document pre-dated with the date that the protocol was signed?
Yes / No
Has the Investigator signed for the IB?
Date IB signed for by the Investigator: / d / d / m / m / y / y
Yes / No
Are there any previous version(s) or receipt(s) of the IB or equivalent documents on file?
Date of version 1: / d / d / m / m / y / y
Date of version 2: / d / d / m / m / y / y
Yes / No
Is there control over the number of IB copies at the site?
Internal Reviewer’s Notes:

______

ETHICS COMMITTEE
Name of EC: ______
Yes / No
EC membership list present and dated?
Study Submission to EC
Date of submission to EC: / d / d / m / m / y / y
Date of EC Approval: / d / d / m / m / y / y
Date of letter from EC: / d / d / m / m / y / y
Yes / No
Were any actions required? If yes, document below:

______

Annual Reports to EC
Yes / No
EC Annual Reports Present?
Date of EC Annual Report: / d / d / m / m / y / y
Date of EC Letter: / d / d / m / m / y / y
Action(s) taken by EC/IRB:

______

Final Report to EC
Yes / No
Has a Final Report for this study been submitted to the EC?
Date of Final Report to EC / d / d / m / m / y / y
Action(s) taken by EC:

______

Serious Adverse Events (SAE) Reports Sent to EC
Timeframes for Reporting Events (Sponsor/coordinating Investigator)
Serious Adverse Events / Reporting Time Frame*

All local unexpected and expected drug related SAEs, irrespective of the treatment, involving human subjects of research.

/  7 days from the date that the Investigator became aware of the event.

All overseas reports of fatal and/or life threatening expected and unexpected SAEs.

/  15 days from the date that the Investigator receives a formal written report of the event.

All overseas reports of other expected and/or unexpected reactions, which are not fatal or life threatening.

/  15 days from the date that the Investigator receives a formal written report of the event.
Yes / No
Have any SAE reports been sent to the EC? If yes, list details below:
Number of days lapsed:
SITE SPECIFIC SAEs
Subject No. / SAE Details / Date Form Completed / EC Informed / Reported within 24 hours
Yes / No / Yes / No
______/ ______/ ______
______/ ______/ ______
______/ ______/ ______
______/ ______/ ______
______/ ______/ ______
Have all SAEs been reported to the Sponsor within 24 hours?
If no, provide details below: / Yes / No
______
______
______
______
the Danish Health and Medicines Authority (SST) AND OTHER APPROVALS
Yes / No
Was SSTA approval of the protocol obtained?
What kind of submission was submitted?
______
______
Date submitted / d / d / m / m / y / y
Yes / No
Any actions required by SST? If yes, state below:
______
______
______
Notes:
______
______
______
FACILITIES - LABORATORY/EQUIPMENT/RECORD STORAGE

Type(s) of laboratory used:

Local
Central
Yes / No
Laboratory certificate(s) - specify types below:
______
______
Yes / No
Are storage of biological samples?
Where and how? / Yes / No
Are laboratory normal ranges present?
Record Storage
Yes / No
Is the storage facility and adequate archive for the study records?
Is there space available for storage of study records?
Is the area a secure area e.g. restricted access, fire flood?
Duration of storage confirmed and appropriate labeling of records
Notes:
______
______
______
______
______
______
______
______
MONITORING
Yes / No
Is the monitoring frequency documented?
Yes / No
Is a pre-study report present?
Date of initiation report / d / d / m / m / m / y / y / y / y
Yes / No
Study closed visit report present?
Date of closeout visit report / d / d / m / m / m / y / y / y / y
Yes / No
Is there any Telephone Contact Report present?
Write the type of Source Data Verification (SDV) performed:
______
______
Yes / No
Was a source document agreement utilized?
Is the frequency of monitoring visits appropriate?
Source documents identified and defined?
Is there adequate follow-up documentation of issues?
Is monitoring report content adequate?
Were monitoring reports reviewed?
Notes:
______
______
______
______
______
FORM FDA 1572 - If applicable
Initial FDA 1572 Form present? / Yes / No
INVESTIGATIONAL PRODUCT
Yes / No
Investigational product storage areas secure?
Yes / No
Investigational product stored in correct conditions?
Yes / No
Temperature logs available?
Yes / No
Initial shipping record to site?
Yes / No
Re-supply shipping record to site?
Yes / No
Subject numbers allocated sequentially?
Yes / No
Investigational product used before expiry date?
Yes / No
Investigational product present in-house?
Yes / No
Unused investigational product in present in-house?
Are there complete, consistent records for the dispensing and return of investigational products on a by patient basis? / Yes / No
Are there complete, consistent records for tracking the destruction of the investigational product? / Yes / No
Has there been any reallocation of the investigational product? If yes, indicate who authorized this. / Yes / No
STUDY SITE FILE
Are the following present in the study file?
Documents / Version No. / Date / Yes / No
Site signature Sheet / ______/ ______
Subject Enrolment /ID Log / ______/ ______
Subject screening log (in-house copy to comply with subject confidentiality) / ______/ ______
Site Standard Clarification Agreement / ______/ ______
Un-opened Randomization Envelopes / ______/ ______
Correspondence / ______/ ______
Adequate follow-up for monitoring visits / ______/ ______
Significant issues raised and resolved / ______/ ______
Correspondence (Letters/Email and Faxes) sent to study site staff copied into the Investigator / ______/ ______
Ancillary Forms / ______/ ______
Are there any inconsistencies between equivalent documents filed at the Investigators site and those kept in-house? If yes, describe below / Yes / No
Are there any unexpected documents? Has the study file been kept up to date?
I Notes:
______
______
______
______
______
______
______
SUBJECT INFORMATION SHEET/CONSENT FORM
Yes / No
Is the original copy on-site?
Has it been reviewed, translated and approved (according to local practice)
Does it contain all the ICH elements (refer to checklist)
Is it written in lay language?
Are versions controlled and approved?
Version Number: / ______
Date of approval by EC / d / d / m / m / y / y
Have there been any changes to the consent documentation since the
original approval by the EC has been given? / Yes / No
If yes, provide details below:
______
Notes:
______
______
______
______
______
SUBJECT RECORDS
Are the following documents available for all enrolled subjects?
Documents / Yes / No
Case Report Forms
Consent documentation – Proof of consent given on consent forms
Subject Diaries (If applicable)
Documented medical history
Documentation that subject is in a study
Clear evidence of disease being studied
GPs informed (if applicable)
Source documents available at audit
Notes:
______
______
______
______
GENETIC STUDIES
Yes / No
Has the EC approved the genetic protocol and consent forms?
Date of approval by IEC / d / d / m / m / y / y
Yes / No
Subject independent medical records contain no information relating to genetics protocol?
Consent forms used are versions approved by EC?
Consent forms filed in Investigator file?
Type of analysis matches the Consent Form?
Laboratory requisition forms contain the following:
Yes / No
Protocol number
Investigator ID
Subject Number
Yes / No
Day/time of Collection
Subject Initials
Date of Birth
Gender
Type of Analysis
For a sample of subjects, the following can be verified:
Yes / No
Dates on CRF and lab form match
Lab form faxed on day of sampling
Samples in standard freezer shipped within 1 week
Samples held at -20 degrees Celsius shipped within 3 months
Sample receipt confirmed to investigator
For subjects who have withdrawn consent is:
Yes / No
CRF and notification for genotype sample destruction completed
Form faxed to monitor and lab within 5 days
Lab or Investigator confirmed destruction

Notes:

Internal Reviewer’s Notes:
______
______
______
______
______
______
______
______
COMPUTER RECORDS
Systems
Name of System / Version / Hardware Source / Software Source
______/ ______/ ______/ ______
______/ ______/ ______/ ______
______/ ______/ ______/ ______
Yes / No
Are user manuals available?
Are user manuals current?
Are user manuals adequate?
Are the user manuals accurate?
Have there been any upgrades to the system?
Was the computer system validated?
Is the timing been handled appropriately?
Are reasons given for the changes and documentation available?
Are security procedures available?

Location:

______

Yes / No
Are passwords required to access the system
Back-up of data
Is the system accurate and reliable?
Yes / No
Is training adequate and documented?
What data is entered into the system?

______

Yes / No
Is the System used as a source for any data items?
Who enters the data into the system?
Investigator: / Co-Investigator: / CRC: / Other (specify) ______

How are changes documented?

______

Yes / No
Is there an audit trail?

How does the monitor conduct SDV?

______

How is data transmitted to the Sponsor?

______

What records are retained?

______

SOP No QA1 Appendix A. version 1.