Understand Pathways
|
Element |
Clinical
Trial (CT) Pathway |
Non-Clinical
Research Pathway |
|
Submission
Route |
ISERC-designated
digital review management platform |
ISERC-designated
digital review management platform |
|
Administrative
Screening |
Within 2
working days; includes CT-specific regulatory documents check |
Within 24
hours; standard checklist |
|
If Incomplete |
PI notified; 5
working days to submit missing documents |
PI notified; 5
calendar days to submit missing documents |
|
If Not
Corrected |
Application
archived after 21 days |
Application
archived after 21 days |
|
Reference
Number Assignment |
Unique
reference number assigned on acceptance |
Unique
reference number assigned on acceptance |
|
Categorisation |
Automatically
routed to CT pathway; Full Board review required |
Categorised as
Exempt, Expedited, or Full Board |
|
Reviewer
Assignment |
3 reviewers: 2
from Expert Reviewer Pool (clinical trial competence) + 1 committee member |
1 expert
reviewer + 1 committee member; additional as needed |
|
Review Period |
10 working days |
10 working days |
|
Performance
Target |
<45 days from submission to decision |
<60 days
submission to decision |
|
Post-Approval
Oversight |
SOP 18;
6-monthly progress reports; DSMB reports; SAE reporting |
Annual
continuing review; deviation reporting |
|
PPB
Registration |
Required
(parallel submission to PPB) |
Not applicable
(unless product involved) |
|
Trial
Registration |
PACTR and
international registry before enrolment |
Not required |
|
NACOSTI Permit |
Post-approval;
required at continuing review and audits |
Post-approval;
required at continuing review and audits |
Dual Pathway Overview
|
Element |
Clinical Trial (CT) Pathway |
Non-Clinical Research Pathway |
|
Submission Route |
ISERC-designated digital review
management platform |
ISERC-designated digital review
management platform |
|
Administrative
Screening |
Within 2
working days; includes CT-specific regulatory documents check |
Within 24
hours; standard checklist |
|
If Incomplete |
PI notified; 5 working days to submit
missing documents |
PI notified; 5 calendar days to submit
missing documents |
|
If
Not Corrected |
Application
archived after 21 days |
Application
archived after 21 days |
|
Reference Number Assignment |
Unique reference number assigned on
acceptance |
Unique reference number assigned on
acceptance |
|
Categorisation |
Automatically
routed to CT pathway; Full Board review required |
Categorised as
Exempt, Expedited, or Full Board |
|
Reviewer Assignment |
3 reviewers: 2 from Expert Reviewer
Pool (clinical trial competence) + 1 committee member |
1 expert reviewer + 1 committee member;
additional as needed |
|
Review
Period |
10 working days |
10 working days |
|
Performance Target |
<45 days submission to decision |
<60 days submission to decision |
|
Post-Approval
Oversight |
SOP 18;
6-monthly progress reports; DSMB reports; SAE reporting |
Annual
continuing review; deviation reporting |
|
PPB Registration |
Required (parallel submission to PPB) |
Not applicable (unless product
involved) |
|
Trial
Registration |
PACTR and
international registry before enrolment |
Not required |
|
NACOSTI Permit |
Post-approval; required at continuing
review and audits |
Post-approval; required at continuing
review and audits |