3 steps of Development


Step Activity Responsible person
1 Visit and evaluate the current status (1-2 days) Appointed Supervisor NRCT’s Consultant
2 Developing process (1/2 – 1 year)
SOP writing/revising
Training: SOP, Human in Research Protection
Constitution the new REC
REC office: Staff, Management
Appointed Supervisor
NRCT’s Consultant
FERCIT
REC
3 Follow-up and observe the board meeting Appointed Supervisor NRCT’s consultant


The Processes of Accreditation

Application for SIDCER-NECAST Accreditation


Process Activity Responsible person
1 Application Form + Self-Assessment Form for SIDCER-NECAST SIDCER/FERCAP Coordinator NECAST Coordinator
2 Survey / Accreditation Processes (3-4 days) SIDCER/FERCAP Surveyors (3) NECAST’s Representative (1-2)
3 Survey / Accreditation Findings and Recommendation SIDCER/FERCAP Surveyors NECAST’s Representative
4 Approved Final Report of Survey / Accreditation SIDCER/FERCAP, Surveyors NECAST’s Representative
5 Corrective Action Plan REC/IRB/IEC
6 Accepted/Follow-up /Approval and Granting the Certificate SIDCER/FERCAP, NECAST


The Processes of Accreditation


Application for SIDCER-NECAST Accreditation


Process Activity Responsible person
1 Application Form + Self-Assessment Form for SIDCER-NECAST NECAST’s Office
NECAST’s Coordinator
2 Accreditation Processes (3 -4 days) NECAST’s Auditors (3)
NECAST’s Coordinator
3 Survey / Accreditation Findings and Recommendations NECAST’s Auditors (3)
NECAST’s Coordinator
4 Final Report of Accreditation, Approval NECAST’s Auditors (3)
NECAST’s Working Group
5 Corrective Action Plan REC/IRB/IEC
6 Accepted/Follow-up/Approval and Granting the Certificate NRCT