Sample RRC Calendar for August –October 2016
Sun Mon Tue Wed Thu
A U G U S T
S E P T E M B E R
Fri
Key Points on the RRC Turnaround Time (cont’d)
Sat
1
2*
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
Sun
Mon Tue
If the preliminary decision for a full-board protocol falls on or before the 25th day of the month, then the final deliberation will be on the next month’s agenda meeting (See Sample RRC Calendar for August-October 2016).
If the preliminary decision for a full-board protocol falls after the 25th day of the month
Wed Thu
Fri
Sat
1
2
3
4
5
6*
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
Sun
Mon Tue
Fri
Office of Research and Development
then the final deliberation of decision will be on the next succeeding month’s agenda meeting (See Sample RRC Calendar for AugustOctober 2016).
A protocol is classified as exempt from review if the undertaking is not within the mandate of the Research Review Committee.
Wed Thu
Bicol Regional Training and Teaching Hospital
Guide to the ittee Comm w ie v e R h c r a Rese e Turnaround Tim
Sat 1
O C T O B E R
2
3
4*
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
Suppose a full board protocol was recommended for approval last August 25, it will be deliberated on & finalized on September 6 Regular RRC Meeting. On the other hand, another full board protocol recommended for approval last August 29 will be deliberated on and finalized on October 4, since the decision did not fall before the cut-off date for August for inclusion to the September Regular RRC Meeting.
L2-2016-005-01
L2-2016-005-01 For concerns and queries, please reach us through: Tel. no.: (052) 483—0017 loc. 4205 Email:
[email protected]
Tel. no.: (052) 483—0017 loc. 4205 Email:
[email protected]
The RRC Turnaround Time (Excerpts from the RRC SOPs) Workflow of SOP No. 2.0: Management of Initial Submissions & Resubmissions
STEPS
ACTIVITY
1
Receipt of study document for initial review and determination of completeness of submission or resubmission
2
TIME FRAME
1 day
Coding
3
Entry into logbook/database
4
Determination of type of Review / Action a. SOP 4.1: Expedited Review b. SOP 4.2: Full Review c. Exempt from Review
1 day
Determination of Date of Review
1 day
5
STEPS
ACTIVITY
1 2
3
ACTIVITY Receipt and management of study protocol submissions Classification as expedited review and selection of the Primary Reviewers with or without Independent Consultant Forwarding of study protocol package to primary reviewers
4
Signing of the Confidentiality Agreement and Disclosure of Conflict of Interest and review the protocol package
Receipt and management of study protocol submissions
2
Classification of protocol for full board review
3
Assignment of primary reviewers with or without an independent consultant
1 day
4
Notification to primary reviewers and independent consultants
4 days
5
Forwarding of study protocol package to primary reviewers
4 days
6
Signing of the Confidentiality Agreement and Disclosure of Conflict of Interest and Review of the protocol package
1 day
7
Discussion of technical and ethical issues and arrival at a preliminary decision
10 days
5
Finalization of Review Results & Communication of Decision to Principal Investigator
6
Filing of documents in the protocol file
7
Inclusion of the Review in the Agenda of the next meeting
TIME FRAME 1 day 8
Inclusion of the protocol in the agenda of the next full board meeting
1 day
2 days
1 day
1 day
If the preliminary decision falls on or before the 25th day of the month then the final deliberation of decision will be on the next month’s agenda meeting If the preliminary decision falls after the 25th day of the month then the final deliberation of decision will be on the next succeeding month’s agenda meeting
Presentation of Review Findings during full board meeting
During meeting
10
Deliberation on full board action on the protocol
During meeting
11
Communication of Committee Action (See SOP 6.2: Communicating RRC Decisions)
12
Filing of documents in the protocol file (SOP 7.2: Managing Active Files).
1 day
Only complete submissions and resubmissions are accepted and qualified for the RRC turna-
1 day
9
7 days
1 day
TIME FRAME
1
Workflow of SOP No. 4.1: Expedited Review
STEPS
Key Points on the RRC Turnaround Time
Workflow of SOP No. 4.2: Full Review
round time monitoring.
“RRC Turnaround Time” refers to the period it takes to manage receipt, review, and communicate the decision for a research protocol to the principal investigator.
The RRC turnaround time varies according to the type of review, i.e., expedited, full, or exempt from review.
A protocol classified under expedited review has a maximum turnaround time of fourteen (14) days and is finalized/approved regardless of the Regular RRC Meeting Schedule. This is for the reason that protocols for expedited review do not involve more than minimal risk or vulnerable population groups.
A protocol classified under full review has a maximum turnaround time of six (6) weeks and is finalized/approved during the scheduled Regular RRC Meeting (every 1st Tuesday of the month). This is for the reason that protocols for full review entail more than minimal risk to
Not later than 2 weeks after the full review or Within 6 weeks after acceptance of a complete protocol 1 day
study participants or the study participants belong to vulnerable groups.
