QA&QC

How's important of the quality in research?

• Compliance with this standard provides public assurance

•  GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.

   

• The rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible.

• Correct all answer

    2. What’s different between QC &QA

• QA should be started from the beginning of the study. QC started after the visit.

• QA is the key responsibility of sponsor QC action from the operator. There will be a way to verify quality control before submitting information

• Trial related activities and documents to determine whether the evaluated trial related activities were conducted and the data were recorded, analyzed and accurately reported by CRA only

• Correct all answer

3.      Who is performing QC duties?

• Nadech check all materials per each visit’s requirement 1 week before the participant visit.

• Yaya check all activities that required by protocol per visit checklist after the participant leaves the study clinic and filled in the nurse note.

• Tim checked the CRF. If there is a finding will record in the note and return it to the nurse of the case owner.

• All do not correct.

4.       QC Informed Consent Form, which of the following is correct?

• Patients collect specimens left after examination in

  Research project Recording time must be before the main Inform consent time.

• Verify that volunteers and informed consent staff and other relevant persons present.

  In the process, signed date correct wwitnesses are not required.

• Check the Informed consent form such as Version used must be current, number of pages complete, Symbols on all pages

• Correct all answer

5.     Which of the following means CAPA?

• A CAPA is written to identify a discrepancy or problem in the conduct of the clinical research study

• Note the root cause of the identified problem, identify the corrective action taken to prevent recurrence of the problem.

• The document after done CAPA that the corrective action has resolved the problem and record.

• Correct all answer

6.      Who is responsible for CAPA?

• CRA

• Auditor

• PI/SI, SC/SN

• Correct all answer

7.      Which of the following is true about major deviation?

• The participants developed a rash around the vaccination site one day after visit.

• The copy of the Informed Consent was torn and disappeared after the volunteer collecting blood sample.

• Participant was short of breath, chest tightness, caregivers taken the participant admitted to the hospital.

• All do not correct.

8.      How to preparation for audit?

• Ensure that we have the documents to prove that study has been conducted properly according to ICH-GCP, Local regulation, Institution SOP.

• Should start from the beginning of the study.

• Any concern raised by any party should be documented.

• Correct all answer

9.  HOW to Prepare for an AUDIT?

• Partial IRB Accreditation

• The Participant agrees to join the study.

• The investigator reports the adverse event 15 days after the incident.

• Correct all answer

10.Which one is correct?

• QA is the key responsibility of the sponsor.

• Mistakes do happen, nothing to hide.

• QA should be placed in every step of the study.

• Correct all answer