Get documents about "CTRP_Registry_Non proprietary_Batch_Upload_Template
Document Sample
CTRP Trial Registration Batch Upload Specification V3
I. Getting ready to send the batch file
1. Prior to your initial batch submission please contact NCI Apps Support to gain approval to send batch fi
1a. NCI Apps Support may be reached at ncicb@pop.nci.nih.gov or 888-478-4423
1b. Once step 1a has been accomplished you will no longer need to contact Apps Support prior to sendin
2. Access the NCI Trial Registration application batch upload web page (at https://trials.nci.nih.gov/registry
2a. An Excel spreadsheet (.xls) containing mandatory and optional data for the trial(s)
2b. A separate zip file containing applicable trial documents (e.g. Protocol; IRB approval; Informed Conse
II. Instructions for preparing the trial data file
1. The trial elements required for registration should be listed in the order specified in the Batch Upload D
2. Each trial should be uniquely identified (this can be your cancer center unique trial identifier)
3. This version of the spec:
1) Supports only interventional trials
2) Supports only non-proprietary trials submission
3) Supports amendment to non-proprietary CTRP trials with 'Abstraction Verified Response' and 'Abstract
4) Supports update to non-proprietary CTRP trials with processing status 'Accepted' and above.
5) Supports up to 100 trials per data file
6) Supports multiple grants per trial submitted
7) Supports multiple IND/IDE per submitted trial
8) Supports generic contact for Responsible Party - Sponsor
III. Instructions for preparing the trial documents zip file
1. Rename the document files if names are not unique for avoiding files replacement at compressing.
Ex: prefix files with unique trial identifier XXXX_document_name.document_extension.
2. Make sure each of the document file names prefixed with trial identifiers are unique per trial if prefixing
3. Provide the document names (incl. extension) in the file containing the trial data. Up to 7 files can be sp
4. Zip all trial-related documents. Please do not include any pathname in the zip file.
Note: Please note that some elements will be ignored at update submission to existing CTRO trials.
roval to send batch files to CTRP
upport prior to sending subsequent batch files
als.nci.nih.gov/registry/admin/batchUpload.action) where sites may upload:
oval; Informed Consent; Participating Sites; Change Memo) for the trials in the data file
the Batch Upload Data Element Spec tab in this spreadsheet
identifier)
ponse' and 'Abstraction Verified No Response' processing statuses
and above.
at compressing.
e per trial if prefixing is used.
Up to 7 files can be specified in one single trial record
ng CTRO trials.
Trial Trial data element Required for Required for
elements original amendment
Order submission
1 Unique Trial Identifier Yes Yes
2 Submission Type Yes Yes
3 NCI Trial Identifier Yes
4 Amendment Number
5 Amendment Date Yes
6 Lead Organization Trial Identifier Yes Yes
7 NCT
8 Title Yes Yes
9 Trial Type Yes Yes
10 Primary Purpose Yes Yes
11 Primary Purpose 'Other' value specification Yes if Primary Yes if Primary
Purpose = 'Other' Purpose = 'Other'
12 Phase Yes Yes
13 Phase 'Other' value specification Yes if Phase = Yes if Phase =
'Other' 'Other'
14 [Sponsor] Organization Name Yes Yes
15 [Sponsor] CTEP Organization Number (CTEP
Identifier)
16 [Sponsor] Street Address Yes Yes
17 [Sponsor] City Yes Yes
18 [Sponsor] State/Province Yes for Yes for
US/Canada/Austr US/Canada/Austr
alia alia
19 [Sponsor] Zip/Postal code Yes Yes
20 [Sponsor] Country Yes Yes
21 [Sponsor] Email Address Yes Yes
22 [Sponsor] Phone
23 [Sponsor] TTY
24 [Sponsor] FAX
25 [Sponsor] URL
26 Responsible Party Yes Yes
27 Sponsor Contact Type Yes if Yes if
Responsible Responsible
Party is Sponsor Party is Sponsor
28 [Sponsor Contact] Title Yes if Yes if
Responsible Responsible
Party is Sponsor Party is Sponsor
and Sponsor and Sponsor
Contact Type is Contact Type is
'Generic' 'Generic'
29 [Sponsor Contact] First Name Yes if Yes if
Responsible Responsible
Party is Sponsor Party is Sponsor
and Sponsor and Sponsor
Contact Type is Contact Type is
'Personal' 'Personal'
30 [Sponsor Contact] Middle Name
31 [Sponsor Contact] Last Name Yes if Yes if
Responsible Responsible
Party is Sponsor Party is Sponsor
and Sponsor and Sponsor
Contact Type is Contact Type is
'Personal' 'Personal'
32 [Sponsor Contact] CTEP Person Number (CTEP
Identifier)
33 [Sponsor Contact] Street Address Yes if Yes if
Responsible Responsible
Party is Sponsor Party is Sponsor
and Sponsor and Sponsor
Contact Type is Contact Type is
'Personal' 'Personal'
34 [Sponsor Contact] City Yes if Yes if
Responsible Responsible
Party is Sponsor Party is Sponsor
and Sponsor and Sponsor
Contact Type is Contact Type is
'Personal' 'Personal'
35 [Sponsor Contact] State/Province Yes if country is Yes if country is
USA, Canada or USA, Canada or
Australia and Australia and
Responsible Responsible
Party is Sponsor Party is Sponsor
and Sponsor and Sponsor
36 [Sponsor Contact] Zip/Postal code Yes: if Yes: if
Responsible Responsible
Party is Sponsor Party is Sponsor
and Sponsor and Sponsor
Contact Type is Contact Type is
'Personal' 'Personal'
37 [Sponsor Contact] Country Yes: if Yes: if
Responsible Responsible
Party is Sponsor Party is Sponsor
and Sponsor and Sponsor
Contact Type is Contact Type is
'Personal' 'Personal'
38 [Sponsor Contact] Email Address Yes: if Yes: if
Responsible Responsible
Party is Sponsor Party is Sponsor
39 [Sponsor Contact] Phone Yes: if Yes: if
Responsible Responsible
Party is Sponsor Party is Sponsor
40 [Sponsor Contact] TTY
41 [Sponsor Contact] FAX
42 [Sponsor Contact] URL
43 [Lead Organization] Name Yes Yes
44 [Lead Organization] CTEP Organization Number
(CTEP Identifier)
45 [Lead Organization] Street Address Yes Yes
46 [Lead Organization] City Yes Yes
47 [Lead Organization] State/Province Yes for Yes for
US/Canada/Austr US/Canada/Austr
alia alia
48 [Lead Organization] Zip/Postal code Yes Yes
49 [Lead Organization] Country Yes Yes
50 [Lead Organization] Email Address Yes Yes
51 [Lead Organization] Phone
52 [Lead Organization] TTY
53 [Lead Organization] FAX
54 [Lead Organization] URL
55 [Lead Organization] Organization Type
56 [Principal Investigator] First Name Yes Yes
57 [Principal Investigator] Middle Name
58 [Principal Investigator] Last Name Yes Yes
59 [Principal Investigator] CTEP Person Number (CTEP
Identifier)
60 [Principal Investigator] Street Address Yes Yes
61 [Principal Investigator] City Yes Yes
62 [Principal Investigator] State/Province Yes for Yes for
US/Canada/Austr US/Canada/Austr
alia alia
63 [Principal Investigator] Zip/Postal code Yes Yes
64 [Principal Investigator] Country Yes Yes
65 [Principal Investigator] Email Address Yes Yes
66 [Principal Investigator] Phone Yes Yes
67 [Principal Investigator] TTY
68 [Principal Investigator] FAX
69 [Principal Investigator] URL
70 Summary 4 Funding Category For interventional For interventional
trial only and if trial only and if
Lead Org is NCI- Lead Org is NCI-
designated designated
Cancer Center Cancer Center
71 [Summary 4 Funding Sponsor/Source] Organization Yes Yes
Name
72 [Summary 4 Funding Sponsor/Source] CTEP
Organization Number (CTEP Identifier)
73 [Summary 4 Funding Sponsor/Source] Street Yes Yes
Address
74 [Summary 4 Funding Sponsor/Source] City Yes Yes
75 [Summary 4 Funding Sponsor/Source] Yes if country is Yes if country is
State/Province USA, Canada or USA, Canada or
Australia Australia
76 [Summary 4 Funding Sponsor/Source] Zip/Postal Yes Yes
code
77 [Summary 4 Funding Sponsor/Source ] Country Yes Yes
78 [Summary 4 Funding Sponsor/Source ] Email Yes Yes
Address
79 [Summary 4 Funding Sponsor/Source ] Phone
80 [Summary 4 Funding Sponsor/Source ] TTY
81 [Summary 4 Funding Sponsor/Source ] FAX
82 [Summary 4 Funding Sponsor/Source ] URL
83 Program Code
84 [NIH Grant] Funding Mechanism Yes: if NIH grant Yes: if NIH grant
exists exists
85 [NIH Grant] Institute Code Yes: if NIH grant Yes: if NIH grant
exists exists
86 [NIH Grant] Serial Number Yes: if NIH grant Yes: if NIH grant
exists exists
87 [NIH Grant] NCI Division/Program Code Yes: if NIH grant Yes: if NIH grant
exists exists
88 Current Trial Status Yes Yes
89 Why Study Stopped? Yes if Current Yes if Current
Trial Status is Trial Status is
Withdrawn, Withdrawn,
Temporarily Temporarily
Closed to Closed to
Accrual, Accrual,
Temporarily Temporarily
Closed to Closed to
Accrual and Accrual and
Intervention or Intervention or
Administratively Administratively
Complete Complete
90 Current Trial Status Date Yes Yes
91 Study Start Date Yes Yes
92 Study Start Date Type Yes Yes
93 Primary Completion Date Yes Yes
94 Primary Completion Date Type Yes Yes
95 IND/IDE Type Yes: if IND/IDE Yes: if IND/IDE
trial trial
96 IND/IDE Number Yes: if IND/IDE Yes: if IND/IDE
trial trial
97 IND/IDE Grantor Yes: if IND/IDE Yes: if IND/IDE
trial trial
98 IND/IDE Holder Type Yes: if IND/IDE Yes: if IND/IDE
trial trial
99 [IND/IDE] NIH Institution Yes If IND/IDE Yes If IND/IDE
trial AND trial AND
(IND/IDE Holder (IND/IDE Holder
Type) = NIH Type) = NIH
100 [IND/IDE] NCI Division /Program Yes if IND/IDE Yes if IND/IDE
trial AND If trial AND If
(IND/IDE Holder (IND/IDE Holder
Type) = NCI Type) = NCI
101 [IND/IDE] Has Expanded Access? Yes if IND/IDE Yes if IND/IDE
trial trial
102 [IND/IDE] Expanded Access Status If (Has If (Has
Expanded Expanded
Access?) = Yes Access?) = Yes
103 Oversight Authority Country Yes Yes
104 Oversight Authority Organization Name Yes Yes
105 FDA Regulatory Information Indicator Yes Yes
106 Section 801 Indicator Yes if FDA Yes if FDA
Regulatory Regulatory
Information Information
Indicator is 'Yes' Indicator is 'Yes'
107 Delayed Posting Indicator Yes if section Yes if section
801 Indicator is 801 Indicator is
'Yes' 'Yes'
108 Data Monitoring Committee Appointed Indicator Yes Yes
109 Protocol Document File Name Yes Yes
110 IRB Approval Document File Name Yes Yes
111 Participating Sites Document File Name
112 Informed Consent Document File Name
113 Other Trial Related Document File Name
114 Change Request Document Name Yes
115 Protocol Highlight Document Name
Required for Valid Values Comments
update
Yes
Yes O, A, U O - original submission
(including the first submission to
CTRP); A - amendment
submission to the already
published trial in CTRP; U -
update to the CTRP trial.
Amendment submission can be
accepted only if the trial
processing status is 'Abstraction
Verified Response' or
'Abstraction Verified No
Response'. Update can be
submitted for trials that have
been accepted or have
processing status other than
'Submitted' and 'Rejected'. See
Processing Status Transition tab
for information about trial
processing statuses
Yes This element is applicable to
amendment submission and
update to the CTRP trials only.
This is the trial identifier
assigned by the CTRP.
Amendment can only be
accepted for trials that have
'Abstraction Verified Response'
or 'Abstraction Verified No
Response' processing status in
CTRP. Update can be submitted
for trials that have 'Accepted'
status and above.
This element is applicable to
amendment submission only.
Use amendment number that is
recorded in user's system.
This element is applicable to
amendment submission only.
Use date of amendment as
documented in the amended
protocol document
AS IS in the protocol document
& assigned by the lead
organization (unique in the lead
organization system)
Unique identifier assigned to the
published trials in PRS
(ClinicalTrials.gov)
Max 4000 characters Title from the protocol document
Yes Interventional, Observational Currently only Interventional
trials are accepted
Yes Treatment, Prevention, If 'other' selected, specify in 12
Supportive Care, Screening,
Early Detection, Diagnostic,
Epidemiologic, Outcome,
Observational, Ancillary,
Correlative, Health Service
Research, Other, Basic
Science
Yes if Primary
Purpose = 'Other'
Yes 0, I, I/II, II, II/III, III, IV, Pilot, If 'other' selected, specify in 14
N/A, Other
Yes if Phase =
'Other'
2-letter state/province code
required for US/Canada, 2-3
letter code required for
Australia
3-letter country code required
Include Phone Extension if any
in the same field
PI, Sponsor
Yes if Personal, Generic Used for defining contact type
Responsible for the Responsible Party
Party value is Sponsor (see 27)
provided
Yes if Applicable to the Responsible
Responsible Party=Sponsor Generic Contact
Party value is only
provided and
contact type is
Generic
Yes if Applicable to the Responsible
Responsible Party=Sponsor Personal
Party value is Contact only
provided and
contact type is
Personal
Applicable to the Responsible
Party=Sponsor Personal
Contact only
Yes if Applicable to the Responsible
Responsible Party=Sponsor Personal
Party value is Contact only
provided and
contact type is
Personal
Applicable to the Responsible
Party=Sponsor Personal
Contact only
Yes if Applicable to the Responsible
Responsible Party=Sponsor Personal
Party value is Contact only
provided and
contact type is
Personal
Yes if Applicable to the Responsible
Responsible Party=Sponsor Personal
Party value is Contact only
provided and
contact type is
Personal
Yes if 2-letter state/province code Applicable to the Responsible
Responsible required for US/Canada, 2-3 Party=Sponsor Personal
Party value is letter code required for Contact only
provided and Australia
contact type is
Personal
Yes if Applicable to the Responsible
Responsible Party=Sponsor Personal
Party value is Contact only
provided and
contact type is
Personal
Yes if 3-letter country code required Applicable to the Responsible
Responsible Party=Sponsor Personal
Party value is Contact only
provided and
contact type is
Personal
Yes if
Responsible
Party = Sponsor
value is provided
Yes if Include Phone Extension if any
Responsible in the same field
Party value
=Sponsor is
provided
2-letter state/province code
required for US/Canada, 2-3
letter code required for
Australia
3-letter country code required
Include Phone Extension if any
in the same field
Institution, ordering group,
repository, research based,
cooperative group, cancer
center, consortium, drug
company, network
2-letter state/province code
required for US/Canada, 2-3
letter code required for
Australia
3-letter country code required
Include Phone Extension if any
in the same field
For interventional National, Externally Peer- applicable if Lead Org is NCI-
trial only and if Reviewed, Institutional, designated Cancer Center
Lead Org is NCI- Industrial
designated
Cancer Center
Yes applicable if Lead Org is NCI-
designated Cancer Center
applicable if Lead Org is NCI-
designated Cancer Center
Yes applicable if Lead Org is NCI-
designated Cancer Center
Yes applicable if Lead Org is NCI-
designated Cancer Center
Yes if country is 2-letter state/province code applicable if Lead Org is NCI-
USA, Canada or required for US/Canada, 2-3 designated Cancer Center
Australia letter code required for
Australia
Yes applicable if Lead Org is NCI-
designated Cancer Center
Yes 3-letter country code required applicable if Lead Org is NCI-
designated Cancer Center
Yes applicable if Lead Org is NCI-
designated Cancer Center
applicable if Lead Org is NCI-
designated Cancer Center
Summary 4 element, no LOV
exists, codes are specific to
cancer centers
Yes: if NIH grant Refer Funding Mechanism in If more than one grant is
exists Valid Values worksheet. recorded provide this value for
all grants separated by
semicolon (;)
Yes: if NIH grant Refer Institute Code in Valid If more than one grant is
exists Values worksheet. recorded provide this value for
all grants separated by
semicolon (;)
Yes: if NIH grant format: 5 or 6 digits If more than one grant is
exists recorded provide this value for
all grants separated by
semicolon (;)
Yes: if NIH grant Refer NCI Division/Program Defaults to N/A if not specified. If
exists Code in Valid Values more than one grant is recorded
worksheet. Specify only the provide this value for all grants
code. separated by semicolon (;)
Yes In Review, Approved, Active, 1) Trials with current trial status
Closed to Accrual, Closed to 'Withdrawn' are not accepted for
Accrual and Intervention , the original submission. 2)
Temporarily Closed to Accrual, Submission of amendment or
Temporarily Closed to Accrual update to existing study with
and Intervention, Complete, Completed, Administratively
Administratively Complete are Completed, Withdrawn and
applicable to original Disapproved current trial status
submission, amendment and are not accepted. 3) Please use
update. Withdrawn status is 'In Review' status at submission
only applicable to Update of pre-IRB approved study.
functionality.
Yes if Current Mandatory if Current Trial Status
Trial Status is is Withdrawn, Temporarily
Withdrawn, Closed to Accrual, Temporarily
Temporarily Closed to Accrual and
Closed to Intervention or Administratively
Accrual, Complete
Temporarily
Closed to
Accrual and
Intervention or
Administratively
Complete
Yes Date when the status has came
in effect
Yes Date that enrollment to the
protocol begins
Yes Actual, Anticipated Only current/past date (in
respect to batch upload date) is
accepted for actual type and
only future date is accepted for
anticipated type. 'Anticipated'
type is valid for 'In Review' and
'Approved' and 'Withdrawn'
current trial status only. 'Actual'
type is valid for any other current
trial status besides 'In Review',
'Approved' and 'Withdrawn'. For
more information check State-
Dates tab in this file.
Yes Date that the final subject was
examined or received an
intervention for the purposes of
final collection of data for the
primary outcome, whether the
clinical trial concluded according
to the prespecified protocol or
was terminated
Yes Actual, Anticipated Only current/past date (in
respect to batch upload date) is
accepted for actual type and
only future date is accepted for
anticipated type. 'Actual' type is
valid for 'Administratively
Complete' or 'Complete' current
trial statuses only. 'Anticipated'
type is valid for any other current
trial status besides
'Administratively Complete' or
'Complete'. For more
information check State-Dates
tab in this file.
Yes: if IND/IDE IND, IDE If more than one IND/IDE is
trial recorded provide this value for
all IND/IDE separated by
semicolon (;).
Yes: if IND/IDE If more than one IND/IDE is
trial recorded provide this value for
all IND/IDE separated by
semicolon (;)
Yes: if IND/IDE CDER, CBER, CDRH If more than one IND/IDE is
trial recorded provide this value for
all IND/IDE separated by
semicolon (;)
Yes: if IND/IDE Investigator, Organization, If more than one IND/IDE is
trial Industry, NIH, NCI recorded provide this value for
all IND/IDE separated by
semicolon (;)
Yes If IND/IDE Refer NIH Institution in Valid If more than one IND/IDE is
trial AND Values worksheet. recorded provide this value for
(IND/IDE Holder all IND/IDE separated by
Type) = NIH semicolon (;). If NIH institution is
not applicable to a single
IND/IDE, provide NA as
replacement for the value
Yes if IND/IDE Refer NCI Division/Program If more than one IND/IDE is
trial AND If Code in Valid Values recorded provide this value for
(IND/IDE Holder worksheet. all IND/IDE separated by
Type) = NCI semicolon (;). If NCI
division/program is not
applicable to a single IND/IDE,
provide NA as replacement for
the value
Yes if IND/IDE Yes, No If more than one IND/IDE is
trial recorded provide this value for
all IND/IDE separated by
semicolon (;).
If (Has Available, No longer available, If more than one IND/IDE is
Expanded Temporarily not available, recorded provide this value for
Access?) = Yes Approved for marketing all IND/IDE separated by
semicolon (;). If expanded
access is not applicable to a
single IND/IDE, provide NA as
replacement for the value
Yes see Oversight Authority tab
Yes see Oversight Authority tab
Yes Yes, No Must be 'Yes; if trial includes
IND/IDE
Yes if FDA Yes, No Must be not NULL if FDA
Regulatory Regulatory Information Indicator
Information is 'Yes'
Indicator is 'Yes'
Yes if section Yes, No Must be not NULL if section 801
801 Indicator is Indicator is 'Yes'. Delayed
'Yes' Posting Indicator is applicable
only to study that includes
device intervention
Yes Yes,No
1) Include file extension. 2) If
you have at least two files with
the same name, rename files
(ex. prefix unique trial identifier
to document name). 3)
Submit amended protocol for
amendment submission.
1) Include file extension. 2) if
you have at least two files with
the same name, rename files
(ex. prefix unique trial identifier
to document name). 3)
Submit dummy file if IRB
approval is not required with the
statement 'IRB' approval is not
required'. 4) Submit
dummy file with the following
info: name of Review Board
(address, phone, email) and
Board Affiliation name in case of
pre-IRB approved studies
submission. 5) One IRB
Approval is only needed.
1) Include file extension. 2) f
you have at least two files with
the same name, rename files
(ex. prefix unique trial identifier
to document name). 3)
Requited if case of multi-site trial
and if the participation sites
information is not included in the
protocol document. 4) If
participating site changes
(recruitment status, program
code) or collaborator's info
change occur, submit this
document for amendment or
update
1) Requited if is not included in
the protocol document.2)
Include file extension. 3) f you
have at least two files with the
same name, rename files (ex.
prefix unique trial identifier to
document name).
1) Include file extension. 2) f
you have at least two files with
the same name, rename files
(ex. prefix unique trial identifier
to document name).
1) This element is applicable to
the amendment only and
includes the changes that
occurred in the protocol
document due to amendment. 2)
Include file extension. 3) f you
have at least two files with the
same name, rename files (ex.
prefix unique trial identifier to
document name).
1) This element is applicable to
the amendment only and
includes the protocol document
with highlighted changes from
the previous version. 2) Include
file extension. 3) f you have at
least two files with the same
name, rename files (ex. prefix
unique trial identifier to
document name).
NOTE: These are the valid values for the data elements. They are presented in vertical format - no relation across
Funding Institute
Mechanism Code NCI Division/Program Code
B09 AA CCR
CTEP
C06 AG
DCB
DP1 AI
DP2 AO DCCPS
DCEG
DP3 AR
DTP
D43 AT
DCP
D71 BC
DEA
E11 CA
OD
F05 CB
OSB/SPOREs
F30 CL
CIP
F31 CM
CDP
F32 CN
F33 CO TRP
RRP
F34 CP
N/A
F37 CT
F38 DA
G07 DC
G08 DE
G11 DK
G12 EB
G13 ES
G20 EY
G94 GM
HD4 GW
H13 HB
H25 HC
H28 HD
H50 HG
H57 HI
H62 HL
H64 HO
H75 HR
H79 HV
I01 JT
KD1 LM
KL1 MD
KL2 MH
K01 NB
K02 NR
K05 NS
K06 OD
K07 OF
K08 OL
K12 OR
K14 PC
K18 SC
K22 SF
K23 WH
K24 RC
K25 RG
K26 RM
K30 RR
K99 TW
L30 WT
L32
L40
L50
L60
M01
PL1
PN1
PN2
P01
P20
P30
P40
P41
P42
P50
P51
P60
P76
RC1
RC2
RC3
RL1
RL2
RL5
RL9
RS1
R00
R01
R03
R04
R06
R08
R13
R15
R17
R18
R21
R24
R25
R30
R33
R34
R36
R37
R41
R42
R43
R44
R49
R55
R56
R90
SC1
SC2
SC3
S06
S10
S11
S21
S22
TL1
TU2
T01
T02
T09
T14
T15
T32
T34
T35
T36
T37
T42
T90
UA1
UC1
UC2
UC3
UC6
UC7
UE1
UE2
UD1
UH1
UH2
UH3
UL1
UR3
UR6
UR8
US3
US4
UT1
UT2
U01
U09
U10
U11
U13
U17
U18
U19
U24
U34
U1A
U1Q
U1S
U1T
U1V
U21
U22
U23
U27
U2G
U2R
U30
U32
U36
U38
U41
U42
U43
U44
U45
U47
U48
U49
U50
U51
U52
U53
U54
U55
U56
U57
U58
U59
U60
U61
U62
U65
U66
U75
U79
U81
U82
U83
U84
U87
U90
VF1
X01
X02
X98
Z02
no relation across
NIH Institution
NEI-National Eye Institute
NHLBI-National Heart, Lung, and Blood
Institute
NHGRI-National Human Genome Research
Institute
NIA-National Institute on Aging
NIAAA-National Institute on Alcohol Abuse
and Alcoholism
NIAID-National Institute of Allergy and
Infectious Diseases
NIAMS-National Institute of Arthritis and
Musculoskeletal and Skin Diseases
NIBIB-National Institute of Biomedical
Imaging and Bioengineering
NICHD-Eunice Kennedy Shriver National
Institute of Child Health and Human
Development
NIDCD-National Institute on Deafness and
Other Communication Disorders
NIDCR-National Institute of Dental and
Craniofacial Research
NIDDK-National Institute of Diabetes and
Digestive and Kidney Diseases
NIDA-National Institute on Drug Abuse
NIEHS-National Institute of Environmental
Health Sciences
NIGMS-National Institute of General Medical
Sciences
NIMH-National Institute of Mental Health
NINDS-National Institute of Neurological
Disorders and Stroke
NINR-National Institute of Nursing Research
NLM-National Library of Medicine
CIT-Center for Information Technology
CSR-Center for Scientific Review
FIC-John E. Fogarty International Center for
Advanced Study in the Health Sciences
NCCAM-National Center for Complementary
and Alternative Medicine
NCMHD-National Center on Minority Health
and Health Disparities
NCRR-National Center for Research
Resources (NCRR
CC-NIH Clinical Center
OD-Office of the Director
A B C D E F G
Unique Trial Submission NCI Trial Amendment Amendment Lead NCT
Identifier Type Identifier Number Date Organization
Trial Identifier
1
2 10 O CCG-0903 NCT000123
NCI-2009-
3 1000 A 00001 A1 5/5/2009 RTOG-85-31
4 2001 O GOG-9201
5 3000 O E3993
NCCTG-90-
6 4000 O 60-51
NCI-2009-
7 5000 U 00001
H I J K L
Title Trial Type Primary Primary Purpose Phase
Purpose 'Other' value
specification
1
A Phase I study of Taxol in
2 refractory leukemia in children Interventional Treatment I
Phase III Study of Zoladex
Adjuvant to Radiotherapy in
Unfavorable Prognosis
3 Carcinoma of the Prostate Interventional Treatment III
A Phase I trial of Ifosfamide and
Taxol in refractory Pelvic
4 Malignancies Interventional Treatment I
Phase III study of priming with
granulocyte-macrophage colony
stimulating factor (rhu-gm-
csf)and of three induction
regimens in adult patients (over
55) with acute non-lymphocytic
5 leukemia Interventional Treatment III
Phase III Comparison of
Methotrexate, Vinblastine,
Doxorubicin, and Cisplatin
(MVAC) vs. Doxorubicin and
Cisplatin (AC) in Women with
Advanced Primary or Recurrent
Metastatic Carcinoma of the
6 Uterine Endometrium Interventional Treatment III
An Open-Labeled, Non-
Randomized Phase I Study of
Alvocidib (Flavopiridol)
Administered with Oxaliplatin
and Fluorouracil/Leucovorin in
Patients with Advanced Solid
7 Tumors Interventional Treatment I
M N O P Q
Phase 'Other' [Sponsor] [Sponsor] [Sponsor] Street [Sponsor] City
value Organization Name CTEP Address
specification Organization
Number
1
Children's Oncology
2 Group C001 2115 E Jefferson St Rockville
Radiation Therapy
3 Oncology Group RT0098 200 Water Street New York
Gynecologic
4 Oncology Group GC009 100 Main St Fairfax
Eastern Cooperative
5 Oncology Group EC6000 100 Village Lane Boston
North Central
Cancer Treatment
6 Group NCT123 200 Springdale Rd Hartford
North Central
Cancer Treatment
7 Group NCT123 200 Springdale Rd Hartford
R S T
[Sponsor] [Sponsor] Zip/Postal code [Sponsor] Country
State/Province
1
2 MD 20185 USA
3 NY 22102 USA
4 VA 22032 USA
5 MA 11760 USA
6 CT 33333 USA
7 CT 33333 USA
U V W X Y
[Sponsor] Email [Sponsor] Phone [Sponsor] TTY [Sponsor] FAX [Sponsor]
Address URL
1
2 test@cog.org 222-444-8888
3 mailto@rtog.com 222-444-8888
4 mailto@gog.com 222-444-8888
5 mailto@ecog.com 222-444-8888
6 mailto@ncctg.com 222-444-8888
7 mailto@ncctg.com 222-444-8888
Z AA AB AC AD AE
Responsible Sponsor Sponsor [Sponsor [Sponsor [Sponsor
Party Contact Type Contact Title Contact] First Contact] Middle Contact]
Name Name Last Name
1
2 PI
3 Sponsor Personal Mary Wilson
Clinical Study
4 Sponsor Generic Department
Director of
Clinical Study
5 Sponsor Generic Department
6 Sponsor Personal Todd Wright
Director of
Clinical Study
7 Sponsor Generic Department
AF AG AH AI AJ AK AL
[Sponsor Contact] [Sponsor [Sponsor [Sponsor [Sponsor
CTEP Person Contact]C Contact] [Sponsor Contact] Contact]
Number [Sponsor ity State/Provin Contact] Country Email
Contact] Street ce Zip/Postal Address
1 Address code
2
3 101 Chestnut St Rockville MD 20852 USA mwilson@rtog.com
4 mailto@gog.com
5 mailto@esog.com
6 400 Main St HandersonTN 20390 USA twright@esog.com
7 twright@esog.com
AM AN AO AP AQ AR AS
[Sponsor [Sponsor Contact] TTY [Sponsor [Sponsor [Lead [Lead [Lead
Contact] Contact] Contact] Organization Organization Organization
Phone FAX URL ] Name ] CTEP ] Street
Organization Address
1 Number
Gynecologic
Oncology
2 Group GC009 100 Main St
Children's
Oncology
3 301-111-1111 Group C001 2115 E Jefferson St
North
Central
Cancer
Treatment
4 240-345-4567 Group NCT123 100 Meadow Rd
North
Central
Cancer
Treatment
5 345-345-3456 Group NCT123 100 Meadow Rd
Children's
Oncology
6 607-123-1234 Group C001 2115 E Jefferson St
7 607-123-4567
AT AU AV AW AX
[Lead [Lead Organization] [Lead [Lead [Lead Organization]
Organization] State/Province Organization] Organization] Email Address
City Zip/Postal Country
code
1
2 Fairfax VA 22032 USA
3 Rockville MD 20185 USA
4 Hartford CT 33333 USA
5 Hartford CT 33333 USA
6 Rockville MD 20185 USA
7
AY AZ BA BB BC BD
[Lead Organization] [Lead [Lead [Lead [Lead [Principal
Phone Organization] Organization] Organization] Organization] Investigator]
TTY FAX URL Organization First Name
Type
1
cooperative
2 group Nita
cooperative
3 group Miljenko
cooperative
4 group Maurie
cooperative
5 group Jacob
cooperative
6 group Harry
7
BE BF BG BH BI BJ BK
[Principal [Principal [Principal [Principal [Principal [Principal [Principal
Investigator] Investigator] Investigator] Investigator] Investigator] Investigator] Investigator]
Middle Name Last Name CTEP Person Street City State/Provinc Zip/Postal
Number Address e code
1
2424
2 Seibel 17297 Springdae Rd Milwaukee WI 53186
100 Village
3 B Pilepich 9300 Hill Lane Natick MA 01760
4 Markman 9977 100 Main St Boston MA 34567
100 Old
5 J Rowe 10528 Meadow Rd Houston TX 33323
100 Old
6 Long 6975 Meadow Rd Houston TX 32323
7
BL BM BN BO BP BQ BR
[Principal [Principal [Principal [Principal [Principal [Principal Summary 4
Investigator] Investigator] Investigator] Investigator] Investigator] Investigator] Funding
Country Email Phone TTY FAX URL Category
Address
1
nseibel@cnm 111-111-
2 USA c.org 1111
MPilepich@m
ednet.ucla.ed 111-111-
3 USA u 1112 Institutional
mmarkman@
mdanderson. 111-111-
4 USA org 1113
rowe@ramba
m.health.gov. 111-111-
5 USA il 1114
long.harry@ 111-111-
6 USA mayo.edu 1111
7
BS BT BU BV BW BX BY
[Summary 4 [Summary 4 [Summary 4 [Summary 4 [Summary 4 [Summary 4 [Summary 4
Funding Funding Funding Funding Funding Funding Funding
Sponsor/Sour Sponsor/Sour Sponsor/Sour Sponsor/Sour Sponsor/Sour Sponsor/Sour Sponsor/Sour
ce] ce] CTEP ce] Street ce] City ce] ce] Zip/Postal ce ] Country
1 Organization Organization Address State/Provinc code
Name Number e
2
3 NCI Rockville
2115 E Jefferson MD 20852 USA
4
5
6
7
BZ CA CB CC CD CE CF
[Summary 4 [Summary 4 [Summary 4 [Summary 4 [Summary 4 Program [NIH Grant]
Funding Funding Funding Funding Funding Code Funding
Sponsor/Sour Sponsor/Sour Sponsor/Sour Sponsor/Sour Sponsor/Sour Mechanism
ce ] Email ce ] Phone ce ] TTY ce ] FAX ce ] URL
1 Address
2 1 F34
mailto@ctrp.o 111-111-
3 rg 1111
4 IM K08;CO6
5
6
7 BR
CG CH CI CJ CK CL CM
[NIH Grant] [NIH Grant] [NIH Grant] Current Trial Why Study Current Trial Study Start
Institute Code Serial Number NCI Status Stopped? Status Date Date
Division/Progr
am Code
1
2 AG 72345 CTEP Complete 8/1/2009 2/1/2009
Accrual target
Temporarily was reached
Closed to for this phase
3 Accrual of the study 8/2/2009 1/2/2009
4 HV;AO 97521;012345 CTEP;CTEP In Review 8/3/2009 10/3/2009
5 Approved 8/4/2009 10/4/2009
Administrativ Closed
6 ely Complete prematurely 8/5/2009 1/5/2009
7 Approved 8/1/2009 12/1/2009
CN CO CP CQ CR CS CT
Study Start Primary Primary IND/IDE Type IND/IDE IND/IDE IND/IDE
Date Type Completion Completion Number Grantor Holder Type
Date Date Type
1
2 Actual 8/1/2009 Actual
3 Actual 10/2/2010 Anticipated
4 Anticipated 10/3/2011 Anticipated
5 Anticipated 9/4/20012 Anticipated
6 Actual 8/5/2009 Actual IND;IND 67899;10,264 CDER;CDER NIH;NCI
7 Anticipated 12/1/2010 Anticipated
CU CV CW CX CY CZ DA
[IND/IDE] [IND/IDE] [IND/IDE] [IND/IDE] Oversight Oversight FDA
NIH NCI Division Has Expanded Authority Authority Regulatory
Institution /Program Expanded Access Country Organization Information
Access? Status Name Indicator
1
United States Federal No
Government
2
United States Federal No
Government
3
United States Food and Yes
Drug
Administratio
n
4
United States Federal No
Government
5
United States Federal No
Government
NA;Approved
6 NIA;NA NA;DCP No;Yes for marketing
United States Federal No
Government
7
DB DC DD DE DF DG DH
Section 801 Delayed Data Protocol IRB Approval Participating Informed
Indicator Posting Monitoring Document Document Sites Consent
Indicator Committee File Name File Name Document Document
Appointed File Name File Name
1 Indicator
Yes protocol_doc
ument_T10.d IRB_Approval Participating_ 10_Informed_
2 oc .doc Sites_T10.xls Consent.PDF
Yes
protocol_doc IRB_Approval Participating_
ument_T1000 _06082007.d Sites_T1000_
3 .doc oc new.xls
Yes No Yes
protocol_doc Participating_ Informed_Co
ument_T2001 IRB_Approval Sites_T2001. nsent_T2001.
4 .doc _T2001.doc xls PDF
Yes
3000_protoco 3000_Particip 3000_Informe
l_document.d 3000_IRB_Ap ating_Sites.xl d_Consent.P
5 oc proval.doc s DF
Yes
4000_protoco 4000_Particip 4000_Informe
l_document.d 4000_IRB_Ap ating_Sites.xl d_Consent.P
6 oc proval.doc s DF
Yes
7
DI DJ DK
Other Trial Change Protocol
Related Memo Highlight
Document Document Document
File Name Name Name
1
10_Other_do
2 cument.doc
changememo
_document_1
3 234.doc
Other_docum
ent_T2001.do
4 c
3000_Other_
document.do
5 c
4000_Other_
document.do
6 c
7
NCI Division/Program Code Definition
CCR Center for Cancer Research
CTEP Cancer Therapy Evaluation Program
DCB Division of Cancer Biology
DCCPS Division of Cancer Control and Population
Sciences
DCEG Division of Cancer Epidemiology and
Genetics
DTP Developmental Therapeutics Program
DCP Division of Cancer Prevention
DEA Division of Extramural Activities
OD Office of the Director, NCI, NIH
OSB/SPOREs Organ Systems Branch (OSB) /Specialized
Programs of Research Excellence
(SPOREs)
CIP Cancer Imaging Program
CDP Cancer Diagnosis Program
TRP Translational Research Program
RRP Radiation Research Program
N/A Not applicable
Country 3-letter code
AFGHANISTAN AFG
ALBANIA ALB
ALGERIA DZA
AMERICAN SAMOA ASM
ANDORRA AND
ANGOLA AGO
ANGUILLA AIA
ANTARCTICA ATA
ANTIGUA AND BARBUDA ATG
ARGENTINA ARG
ARMENIA ARM
ARUBA ABW
AUSTRALIA AUS
AUSTRIA AUT
AZERBAIJAN AZE
BAHAMAS BHS
BAHRAIN BHR
BANGLADESH BGD
BARBADOS BRB
BELARUS BLR
BELGIUM BEL
BELIZE BLZ
BENIN BEN
BERMUDA BMU
BHUTAN BTN
BOLIVIA BOL
BOSNIA AND HERZEGOWINA BIH
BOTSWANA BWA
BOUVET ISLAND BVT
BRAZIL BRA
BRITISH INDIAN OCEAN TERRITORY IOT
BRUNEI DARUSSALAM BRN
BULGARIA BGR
BURKINA FASO BFA
BURUNDI BDI
CAMBODIA KHM
CAMEROON CMR
CANADA CAN
CAPE VERDE CPV
CAYMAN ISLANDS CYM
CENTRAL AFRICAN REPUBLIC CAF
CHAD TCD
CHILE CHL
CHINA CHN
CHRISTMAS ISLAND CXR
COCOS (KEELING) ISLANDS CCK
COLOMBIA COL
COMOROS COM
CONGO COG
COOK ISLANDS COK
COSTA RICA CRI
COTE D'IVOIRE CIV
CROATIA (local name: Hrvatska) HRV
CUBA CUB
CYPRUS CYP
CZECH REPUBLIC CZE
DENMARK DNK
DJIBOUTI DJI
DOMINICA DMA
DOMINICAN REPUBLIC DOM
EAST TIMOR TMP
ECUADOR ECU
EGYPT EGY
EL SALVADOR SLV
EQUATORIAL GUINEA GNQ
ERITREA ERI
ESTONIA EST
ETHIOPIA ETH
FALKLAND ISLANDS (MALVINAS) FLK
FAROE ISLANDS FRO
FIJI FJI
FINLAND FIN
FRANCE FRA
FRANCE, METROPOLITAN FXX
FRENCH GUIANA GUF
FRENCH POLYNESIA PYF
FRENCH SOUTHERN TERRITORIES ATF
GABON GAB
GAMBIA GMB
GEORGIA GEO
GERMANY DEU
GHANA GHA
GIBRALTAR GIB
GREECE GRC
GREENLAND GRL
GRENADA GRD
GUADELOUPE GLP
GUAM GUM
GUATEMALA GTM
GUINEA GIN
GUINEA-BISSAU GNB
GUYANA GUY
HAITI HTI
HEARD AND MC DONALD ISLANDS HMD
HOLY SEE (VATICAN CITY STATE) VAT
HONDURAS HND
HONG KONG HKG
HUNGARY HUN
ICELAND ISL
INDIA IND
INDONESIA IDN
IRAN (ISLAMIC REPUBLIC OF) IRN
IRAQ IRQ
IRELAND IRL
ISRAEL ISR
ITALY ITA
JAMAICA JAM
JAPAN JPN
JORDAN JOR
KAZAKHSTAN KAZ
KENYA KEN
KIRIBATI KIR
KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF PRK
KOREA, REPUBLIC OF KOR
KUWAIT KWT
KYRGYZSTAN KGZ
LAO PEOPLE'S DEMOCRATIC REPUBLIC LAO
LATVIA LVA
LEBANON LBN
LESOTHO LSO
LIBERIA LBR
LIBYAN ARAB JAMAHIRIYA LBY
LIECHTENSTEIN LIE
LITHUANIA LTU
LUXEMBOURG LUX
MACAU MAC
MACEDONIA, THE FORMER YUGOSLAV REPUBLIC OF MKD
MADAGASCAR MDG
MALAWI MWI
MALAYSIA MYS
MALDIVES MDV
MALI MLI
MALTA MLT
MARSHALL ISLANDS MHL
MARTINIQUE MTQ
MAURITANIA MRT
MAURITIUS MUS
MAYOTTE MYT
MEXICO MEX
MICRONESIA, FEDERATED STATES OF FSM
MOLDOVA, REPUBLIC OF MDA
MONACO MCO
MONGOLIA MNG
MONTSERRAT MSR
MOROCCO MAR
MOZAMBIQUE MOZ
MYANMAR MMR
NAMIBIA NAM
NAURU NRU
NEPAL NPL
NETHERLANDS NLD
NETHERLANDS ANTILLES ANT
NEW CALEDONIA NCL
NEW ZEALAND NZL
NICARAGUA NIC
NIGER NER
NIGERIA NGA
NIUE NIU
NORFOLK ISLAND NFK
NORTHERN MARIANA ISLANDS MNP
NORWAY NOR
OMAN OMN
PAKISTAN PAK
PALAU PLW
PANAMA PAN
PAPUA NEW GUINEA PNG
PARAGUAY PRY
PERU PER
PHILIPPINES PHL
PITCAIRN PCN
POLAND POL
PORTUGAL PRT
PUERTO RICO PRI
QATAR QAT
REUNION REU
ROMANIA ROM
RUSSIAN FEDERATION RUS
RWANDA RWA
SAINT KITTS AND NEVIS KNA
SAINT LUCIA LCA
SAINT VINCENT AND THE GRENADINES VCT
SAMOA WSM
SAN MARINO SMR
SAO TOME AND PRINCIPE STP
SAUDI ARABIA SAU
SENEGAL SEN
SEYCHELLES SYC
SIERRA LEONE SLE
SINGAPORE SGP
SLOVAKIA (Slovak Republic) SVK
SLOVENIA SVN
SOLOMON ISLANDS SLB
SOMALIA SOM
SOUTH AFRICA ZAF
SOUTH GEORGIA AND THE SOUTH SANDWICH ISLANDS SGS
SPAIN ESP
SRI LANKA LKA
ST. HELENA SHN
ST. PIERRE AND MIQUELON SPM
SUDAN SDN
SURINAME SUR
SVALBARD AND JAN MAYEN ISLANDS SJM
SWAZILAND SWZ
SWEDEN SWE
SWITZERLAND CHE
SYRIAN ARAB REPUBLIC SYR
TAIWAN, PROVINCE OF CHINA TWN
TAJIKISTAN TJK
TANZANIA, UNITED REPUBLIC OF TZA
THAILAND THA
TOGO TGO
TOKELAU TKL
TONGA TON
TRINIDAD AND TOBAGO TTO
TUNISIA TUN
TURKEY TUR
TURKMENISTAN TKM
TURKS AND CAICOS ISLANDS TCA
TUVALU TUV
UGANDA UGA
UKRAINE UKR
UNITED ARAB EMIRATES ARE
UNITED KINGDOM GBR
UNITED STATES USA
UNITED STATES MINOR OUTLYING ISLANDS UMI
URUGUAY URY
UZBEKISTAN UZB
VANUATU VUT
VENEZUELA VEN
VIET NAM VNM
VIRGIN ISLANDS (BRITISH) VGB
VIRGIN ISLANDS (U.S.) VIR
WALLIS AND FUTUNA ISLANDS WLF
WESTERN SAHARA ESH
YEMEN YEM
YUGOSLAVIA YUG
ZAIRE ZAR
ZAMBIA ZMB
ZIMBABWE ZWE
Country Country 3-letter code State/Province
UNITED STATES USA
Alabama
Alaska
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
Florida
Georgia
Hawaii
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana
Nebraska
Nevada
New Hampshire
New Jersey
New Mexico
New York
North Carolina
North Dakota
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
South Dakota
Tennessee
Texas
Utah
Vermont
Virginia
Washington
West Virginia
Wisconsin
Wyoming
CANADA CAN
Alberta
British Columbia
Manitoba
New Brunswick
Newfoundland and Labrador
Northwest Territories
Nova Scotia
Nunavut
Ontario
Prince Edward Island
Quebec
Saskatchewan
Yukon
AUSTRIA AUT
Australian Capital Territory
New South Wales
Northern Territory
Queensland
South Australia
Tasmania
Victoria
Western Australia
2-3 letter state/province code Old values
AL
AK
AZ
AR
CA
CO
CT
DE
FL
GA
HI
ID
IL
IN
IA
KS
KY
LA
ME
MD
MA
MI
MN
MS
MO
MT
NE
NV
NH
NJ
NM
NY
NC
ND
OH
OK
OR
PA
RI
SC
SD
TN
TX
UT
VT
VA
WA
WV
WI
WY
AB
BC
MB
NB
NL
NT
NS
NU
ON
PE
QC
SK
YT
ACT
NSW
NT
QLD
SA
TAS
VIC
WA
Oversight Authority Country Oversight Authority Organization Name
Afghanistan Ministry of Public Health
Algeria Ministry of Health
Argentina Human Research Bioethics Committee
Argentina Administracion Nacional de Medicamentos,
Alimentos y Tecnologia Medica
Australia Department of Health and Ageing
Therapeutic Goods Administration
Australia Human Research Ethics Committee
Australia National Health and Medical Research
Council
Austria Ethikkommission
Austria Agency for Health and Food Safety
Austria Federal Ministry for Health and Women
Austria Federal Office for Safety in Health Care
Bangladesh Bangladesh Medical Research Council
Bangladesh Directorate of Drug Administration
Bangladesh Ethical Review Committee
Belarus Ministry of Health
Belgium Institutional Review Board
Belgium Directorate general for the protection of
Public health: Medicines
Belgium Federal Agency for Medicinal Products and
Health Products
Belgium Ministry of Social Affairs, Public Health and
the Environment
Belgium The Federal Public Service (FPS) Health,
Food Chain Safety and Environment
Bolivia Ethics Committee
Bolivia Ministry of Health
Brazil National Health Surveillance Agency
Brazil Ministry of Health
Brazil National Committee of Ethics in Research
Bulgaria Ministry of Health
Bulgaria Bulgarian Drug Agency
Burkina Faso Ministry of Health
Burkina Faso Ministry for Higher Education and Research
Cambodia Ministry of Health
Cameroon Ministry of Public Health
Canada Canadian Institutes of Health Research
Canada Ethics Review Committee
Canada Health Canada
Canada Ministry of Health & Long Term Care, Ontario
Chile Comisi?n Nacional de Investigaci?n
Cient?fica y Tecnol?gica
Chile Instituto de Salud Publica de Chile
China Ethics Committee
China Ministry of Health
China State Food and Drug Administration
Colombia INVIMA Instituto Nacional de Vigilancia de
Medicamentos y Alimentos
Colombia Institutional Review Board
Croatia Minister of Science, Education and Sports
Croatia Ministry of Health and Social Care
Czech Republic Ethics Committee
Czech Republic State Institute for Drug Control
Denmark Danish Dataprotection Agency
Denmark Danish Medicines Agency
Denmark Ethics Committee
Denmark National Board of Health
Denmark The Danish National Committee on
Biomedical Research Ethics
Denmark The Ministry of the Interior and Health
Denmark The Regional Committee on Biomedical
Research Ethics
Dominican Republic Secretar?a del Estado de Salud P?blica y
Asistencia Social (SESPAS)
Ecuador Public Health Ministry
Egypt Institutional Review Board
Egypt Ministry of Health and Population
Estonia The State Agency of Medicine
Ethiopia Ethiopia Science and Technology
Commission
Finland Ethics Committee
Finland Ministry of Social Affairs and Health
Finland National Agency for Medicines
France Afssaps - French Health Products Safety
Agency
France Direction G?n?rale de la Sant?
France French Data Protection Authority
France Institutional Ethical Committee
France Ministry of Health
France National Consultative Ethics Committee for
Health and Life Sciences
Gambia Department of State for Health and Social
Welfare
Gambia MRC Ethics Committee
Georgia Ministry of Health
Germany Federal Ministry of Food, Agriculture and
Consumer Protection
Germany Federal Ministry of Education and Research
Germany Federal Institute for Drugs and Medical
Devices
Germany Ethics Commission
Germany Paul-Ehrlich-Institut
Ghana Committee on Human Research
Ghana Ministry of Health
Greece National Organization of Medicines
Greece Ethics Committee
Greece Ministry of Health and Welfare
Guinea-Bissau Ministry of Health
Hong Kong Joint CUHK-NTEC Clinical Research Ethics
Committee
Hong Kong Ethics Committee
Hong Kong Department of Health
Hungary National Institute of Pharmacy
Iceland Ministry of Health and Social Security
Iceland Icelandic Medicines Control Agency
India Science and Engineering Research Council
India Institutional Review Board
India Ministry of Science and Technology
India Ministry of Health
India Department of Atomic Energy
India Drugs Controller General of India
India Indian Council of Medical Research
Ireland Ministry of Health
Ireland Medical Ethics Research Committee
Ireland Irish Medicines Board
Israel Ethics Commission
Israel Ministry of Health
Israel Israeli Health Ministry Pharmaceutical
Administration
Israel The Israel National Institute for Health Policy
Research and Health Services Research
Italy Ministry of Health
Italy National Monitoring Centre for Clinical Trials -
Ministry of Health
Italy Ethics Committee
Italy National Institute of Health
Italy National Bioethics Committee
Italy The Italian Medicines Agency
Jamaica Ministry of Health
Japan Foundation for Biomedical Research and
Innovation
Japan Pharmaceuticals and Medical Devices
Agency
Japan Ministry of Health, Labor and Welfare
Japan Ministry of Education, Culture, Sports,
Science and Technology
Japan Institutional Review Board
Jordan Ethical Committee
Kazakhstan Ethical Commission
Kenya Ethical Reveiw Committee
Kenya Institutional Review Board
Kenya Ministry of Health
Latvia State Agency of Medicines
Lebanon Ministry of Public Health
Lebanon Institutional Review Board
Liechtenstein Control Authority for Medicinal Products
Lithuania Bioethics Committee
Lithuania State Medicine Control Agency - Ministry of
Health
Macedonia Ethics Committee
Malawi National Health Sciences Research
Committee
Malawi College of Medicine Research and Ethics
Committee
Malaysia Ministry of Health
Mali Ministry of Health
Mauritius Ministry of Health and Quality of Life
Mexico National Council of Science and Technology
Mexico Ethics Committee
Mexico Federal Commission for Protection Against
Health Risks
Mexico Ministry of Health
Mexico National Institute of Public Health, Health
Secretariat
Mexico Federal Commission for Sanitary Risks
Protection
Morocco Ministry of Public Health
Mozambique Ministry of Health (MISAU)
Netherlands The Central Committee on Research
Involving Human Subjects (CCMO)
Netherlands Dutch Health Care Inspectorate
Netherlands Medical Ethics Review Committee (METC)
Netherlands Medicines Evaluation Board (MEB)
Netherlands Independent Ethics Committee
New Zealand Health Research Council
New Zealand Food Safety Authority
New Zealand Health and Disability Ethics Committees
New Zealand Institutional Review Board
New Zealand Medsafe
Nigeria The National Agency for Food and Drug
Administration and Control
Norway Data Inspectorate
Norway The National Committees for Research
Ethics in Norway
Norway Norwegian Medicines Agency
Norway Norwegian Institute of Public Health
Norway Directorate for Health and Social Affairs
Norway Norwegian Social Science Data Services
Pakistan Ministry of Health
Pakistan Research Ethics Committee
Panama Ministry of Health
Peru Ethics Committee
Peru Ministry of Health
Peru General Directorate of Pharmaceuticals,
Devices, and Drugs
Philippines Bureau of Food and Drugs
Philippines Department of Health
Poland Ministry of Scientific Research and
Information Technology
Poland Drug Institute
Poland Ministry of Health
Poland Office for Registration of Medicinal Products,
Medical Devices and Biocidal Products
Portugal Ethics Committee for Clinical Research
Portugal National Pharmacy and Medicines Institute
Portugal Health Ethic Committee
Romania National Medicines Agency
Romania State Institute for Drug Control
Saudi Arabia Research Advisory Council
Saudi Arabia Ministry of Health
Senegal Ministere de la sante
Serbia Ethics Committee
Sierra Leone Ministry of Health and Sanitation
Singapore Health Sciences Authority
Singapore Domain Specific Review Boards
Singapore Clinical Trials & Epidemiology Research Unit
(CTERU)
Slovenia Agency for Medicinal Products - Ministry of
Health
Slovenia Ministry of Health
South Africa National Health Research Ethics Council
South Africa Medicines Control Council
South Africa Department of Health
Spain Ministry of Health
Spain Spanish Agency of Medicines
Spain Ministry of Health and Consumption
Spain Comit? ?tico de Investigaci?n Cl?nica
Spain Ethics Committee
Sri Lanka Ministry of Healthcare & Nutrition
Sudan Ministry of Health
Sweden Medical Products Agency
Sweden The National Board of Health and Welfare
Sweden Swedish National Council on Medical Ethics
Sweden Regional Ethical Review Board
Sweden Institutional Review Board
Switzerland Ethikkommision
Switzerland Federal Office of Public Health
Switzerland Swissmedic
Switzerland Laws and standards
Taiwan Department of Health
Taiwan National Bureau of Controlled Drugs
Taiwan Institutional Review Board
Tanzania National Institute for Medical Research
Tanzania Food & Drug Administration
Tanzania Ministry of Health
Thailand Ethical Committee
Thailand Khon Kaen University Ethics Committee for
Human Research
Thailand Food and Drug Administration
Thailand Ministry of Public Health
Tunisia Office of Pharmacies and Medicines
Tunisia Ministry of Public Health
Turkey Ethics Committee
Turkey Ministry of Health
Uganda Research Ethics Committee
Uganda Ministry of Health
Uganda National Council for Science and Technology
Ukraine State Pharmacological Center - Ministry of
Health
Ukraine Ministry of Health
United Arab Emirates General Authority for Health Services for Abu
Dhabi
United Arab Emirates Drug Control Department - Medicines and
Pharmacy Control - Ministry of Health
United Kingdom Food Standards Agency
United Kingdom Medicines and Healthcare Products
Regulatory Agency
United Kingdom Research Ethics Committee
United Kingdom National Health Service
United Kingdom Department of Health
United States Federal Government
United States Institutional Review Board
United States Food and Drug Administration
Zambia Research Ethics Committee
Zambia Ministry of Health
Zimbabwe Medical Research Council
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