1. |
What
is a clinical trial? |
2. |
What
trials are included in the HAREC Clinical Trial Registry database? |
3. |
Are
there charges for using the Registry database? |
4. |
How
do I cite a clinical trial in the Registry database? |
5. |
Who
is responsible for registering a trial? |
6. |
Which
registers are acceptable? |
7. |
I
am a researcher. When do I register a clinical trial? |
8. |
What
information needs to be registered in the HAREC Registry? |
9. |
How
do I contact HAREC Clinical Trial Registry for help? |
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1. |
What
is a clinical trial? |
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For
information about clinical trials, please refer to About
Clinical Trials. |
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2. |
What
trials are included in the HAREC Clinical Trial Registry database? |
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The
HAREC Clinical Trial Registry includes clinical trials involving
patients in Hong Kong and approved by the appropriate authority.
Any such clinical trial can be registered with the HAREC Clinical
Trial Registry. |
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3. |
Are
there charges for using the Registry database? |
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No.
The Registry is free for all to view and access. |
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4. |
How
do I cite a clinical trial in the Registry database? |
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If
you want to cite information from the Registry database in any
publication or for distribution, please state the source of the
data and the date accessed, in this format: |
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Primary
Sponsor; Secondary Sponsor(s). Public Title. In: HAREC Clinical
Trial Registry [Internet]. Hong Kong: Hospital Authority; 2005-
[cited date]. Available from: http://www.ekg.org.hk/HAREC-CTR/RegistryDisplay2.jsp?HARECID=HARECCTR0500123
Trial ID No.: HARECCTR0500123. |
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[Note:
The "cited date" is the date the record was accessed.
Dates are in the format: YYYYMMMDD.] |
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Example: |
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Hospital
Authority. The effects of Tai Chi on the prevention of falls
in the elderly. In: HAREC Clinical Trial Registry [Internet].
Hong Kong: Hospital Authority; 2005- [cited 2005 Sep 7]. Available
from: http://www.ekg.org.hk/HAREC-CTR/RegistryDisplay2.jsp?HARECID=HARECCTR0500123
Trial ID No.: HARECCTR0500123. |
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5. |
Who
is responsible for registering a trial? |
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The
"Responsible Registrant" for a trial is either the principal
investigator (PI) or the co-investigators (CIs). The submitting
party is responsible for the accuracy of the data as well as the
completeness of the dataset, as required by ICMJE / WHO ICTRP
at the time of submission. The Registry reserves the right to
request additional data as required by WHO ICTRP or ICMJE from
time to time. |
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The
submitting party is responsible to update the Registry with the
following information: |
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a. |
Changes
in the patient recruitment status; |
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b. |
Any
changes in the trial information provided in this form; |
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c. |
Any
condition leading to premature termination. |
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6. |
Which
registers are acceptable? |
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ICMJE
has recognized five Registries as of January 2006 and they are: ACTR (Australia), ClinicalTrials.gov (United States), ISRCTN (United Kingdom), UMIN-CTR (Japan), Nederlands
Trial Register (Netherlands), and will review other Registries
before their next annual meeting (anticipated to be around April
2007). |
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WHO
ICTRP plans to launch Member
Register network in 1st Quarter, 2006. The Network composes
of Member Registers and Associate Registers. Member Registers
will mainly be national or regional registers, and Associate Registers
may establish an Associate Membership agreement with a single
Member Register to ensure that the trial is affiliated with only
one Member Register. |
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7. |
I
am a researcher. When do I register a clinical trial? |
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If
investigators wish to publish their clinical trial results eventually
in ICMJE
member journals, they must register the trial at or before
the onset of patient enrollment. This applies to any clinical
trial starting enrollment after 1 July 2005. |
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For
trials that began enrollment before 1 July 2005, the ICMJE member
journals will consider for publication only if the trial is adequately
registered before
journal submission. |
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8. |
What
information needs to be registered in the HAREC Registry? |
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The
HAREC Clinical Trial Registry contains the trial information that
complies with international standard on trial registration being
developed by the WHO
International Committee on Trial Registration Platform (ICTRP) and ICMJE.
Information kept in the Registry is intended to be kept permanently. |
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For
detail information, please refer to Information
for Investigators |
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9. |
How
do I contact HAREC Clinical Trial Registry for help? |
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Please
email HAREC-CTR@ha.org.hk. |
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HAREC
Clinical Trial Registry Administrator
Last Update Date: 9 Feb 2012
Create Date: 31 August 2005 |
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