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Table 2 Screening audit checklist derived by Severance Hospital

From: ‘Screening audit’ as a quality assurance tool in good clinical practice compliant research environments

Questions

Yes/No

If no, it counts on the following category

Study team has secured and kept a delegation log. (e.g., name, duration of study participation, role, signature, etc.).

 

Failure to maintain essential documents

Study team has been trained according to the HRPP P&P and its certificate are maintained with their CV.

 

Study team maintains relevant documents with IRB such as IRB application, IRB approval letter, and IRB roaster.

 

Study team maintains documents such as protocol, case report form, informed consent form, etc. submitted to the IRB with all revised versions.

 

Study team maintains participant logs; Participant screening log, Enrollment log, Randomization code (if, applicable), Identification log.

 

Study team maintains completed case report form of each enrolled participant.

 

All items that the investigators must fill out are completed.

 

Inappropriateness of documents

No errors were discovered when browse through the documents.

 

Study team has followed CRF guidelines regarding documentation and correction.

 

PI signed in the completed CRF.

 

Prior to participation in clinical research, subjects (or their LAR) wrote his/her hand written signature and date on the consent form (including subjects who failed screening test or their LAR)

 

Failure to obtain informed consent

In clinical research with human materials, subjects also wrote his/her hand written signature and date on the statutory consent form from the Bioethics and Safety Act.

 

Principle Investigator or designated and qualified research staff obtained ICF from the subjects.

 

[Witness] In case of the person who cannot read the document (or LAR), the witness attended the consent process, and signed in the consent form while the subject (or LAR) agreed with verbal consent.

 

[Legally Authorized Representative] In case of the person who lacked understanding or expression ability, both subjects and their legally authorized representative signed the consent form.

 

All items that the subject must fill out are completed including optional check.

 

Inappropriateness of informed consent form

No errors were discovered when browse through the documents.

 

Re-consent has been made in case of ICF modification.

 

Study team protect subject’s personal information with identification code.

 

Failure to protect participants’ personal information

Identifiable data (name, hospital number, social number, etc.) is not written on the CRF.