เป็นเพื่อนกับเรา เพื่อสอบถาม และติดตามข่าวสารได้ง่าย และสะดวกมากขึ้น ที่ Line Official account ของ NU-IRB-NRE
Note:
For research projects approved under an Exempt Review, the IRB will issue a Certificate of Exemption (COE) with no expiration date. Investigators may or may not be required to submit a Final Report, depending on the decision of the IRB Chair, Vice Chair, Secretary, or the assigned reviewer. The requirement will be indicated clearly on the certificate. The decision on whether a Final Report is required is based on whether the project involves the collection of personally identifiable information (PII) or data that can be traced back to individual participants. If such identifiable data are collected, Investigators will be required to submit a Final Report upon completion of the study.
If there are any changes to the approved research protocol, the Investigator must submit an Amendment request in all cases.
For research projects approved under Expedited or Full-Board Review, a Certificate of Approval (COA) will be issued. The certificate is valid for 12 months from the date of approval. If the research is not completed within this period, the Investigator must submit a Continuing Review request at least 30 days before the certificate expires.
Any non-compliance or deviation from the approved research protocol must be reported to the Human Research Ethics Committee in all cases.
If the Investigator has completed all research activities and only the manuscript submission for publication remains, the Investigator must submit a Final Report for review by the Human Research Ethics Committee. There is no need to submit progress reports or request continuing approval while awaiting publication. Submission of the Final Report confirms that the research project has concluded. The Investigator may retain the approval letter of the Final Report as official documentation if requested by relevant parties.
This form includes the following submission types:
Serious Adverse Event (SAE)
Suspected Unexpected Serious Adverse Reaction (SUSARs)
Suspected Unexpected Serious Adverse Reaction Line Listing
Independent Data-Monitoring Committee (IDMC)
Data and Safety Monitoring Board (DSMB)
Data Monitoring Committee (DMC)
Other safety report