Page 77 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

APPENDIX 6: NRDHM Checklist

H
R

R
O
V
E

N NATIONAL COMMITTEE FOR RESEARCH AND DEVELOPMENT IN HERBAL

E
A
L
O
I
D
N
O
C
T

T
F
I
E
A
N

L
E
H
A

I
N
S
B
A
L
T
E
E
R

M
C
M
O
R
P
E
M
N
D
T
A
E
R
M
N
(
I
N
D
H
I
C
D
)

M MEDICINE (NRDHM)
E
E

A
S
E

A
S
E
P

N
A
G
B
E
K
Y
N
A
N
P
E

A
K
T
I
M
B
D
J JAWATANKUASA KEBANGSAAN PENYELIDIKAN DAN PEMBANGUNAN
N

A
W
N
A
A
N
A
K
I
A
N
U
L
U
A
G
N
N
A
D
H
T
U
H
A
A
B
N

J
P PERUBATAN HERBA (JKPPH) )
K
E
(

E
A
P
R
P
R
B

D
U

Y
T

O
R
C
O
T
F

L
S
O
P
O
R

E
T
T
E
R
P
E
X
J
E
B
S SUBJECT-MATTER EXPERT REVIEW OF STUDY PROTOCOL
U
M
A
-
C
T
R
E
T

W
E
V
I
1. Please find below the details of information that are required to be included in the study
proposal and Investigator’s Brochure (if relevant) for studies that involve herb/s as the test item.
k
l
c
h
e
i
t
2. This form is meant as a c checklist only, it is not meant to be filled in.

s
3. NRDHM will be reviewing the study protocol and Investigator’s brochure (if relevant).
D

N
F
I
A A. BACKGROUND INFORMATION
B

K
A
C
.
U
N
O
G
R
O
I
T
N
O
M
R
A
1 Study protocol title

2 Principal investigator Name
Contact details (Address, phone number/s, email)
3 Clinical Research Organization Name
Contact details (Address, phone number/s, email)
4 Sponsor Name
Contact details (Address, phone number/s, email)

B. STUDY DESIGN
5 Objective(s) of the study

6 Endpoint(s) of the study
7 Type of study  eg Cohort, Cross over trial, RCT etc
 Sampling size calculation

8 Control group Details on the comparison group
(Placebo or standard treatment)
9 Target group of treatment  Intended group: Adult, Adolescent / Teenager,
Children, Women of Childbearing age
 Intended Disease /condition
10 Duration of treatment Please state specifically how long the treatment is
planned for:
1. Not more or equal to 14 days
2. More than 14 days till 3 months
3. Long term (More than 3 months)
11 Mode of delivery How will the test item be taken by the patients?
Oral, Topical application, Intravenous,
Subcutaneous and others
12 Dosing Amount and frequency
New dose?
NRDHM HERBAL TEST ITEM FOR STUDIES Ver3.1 Mar2015 1

NIH Guidelines for Conducting Research in MOH, 2021 61