Operation of CRMC website
16th September 2015
Prof. Juliana CHAN
Director, CRMO
12th Feb 2015
Clinical Research Management Office
臨床研究統籌處
• A set-up joint office of NTEC and CUHK to enhance the
quality standard, efficiency and compliance of clinical
trials.
• Implements clinical research policies set by CRMC
(Clinical Research Management Committee) and
coordinate activities to improve the safety of research
subjects, the integrity of research conduct and the
compliance of regulatory requirements in accordance
to Good Clinical Practice (GCP).
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CRMC website
http://www.crmc.med.cuhk.edu.hk
• English version
• Chinese version (Simplified Chinese or Traditional Chinese) for selected sections
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Before Login
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Login
http://www.crmc.med.cuhk.edu.hk
Username: CU/ HA email login
Password: Generated and sent to “team list” members (can
be changed)
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Login
1. Type your username and password
2. Click Login button
3. Retrieve password if you forget it
3a. Fill in username (your
CUHK/ HA email address)
and Security Code
A password will send to
your email address stated
3b. Click “Send Password” in the “username” in few
minutes.
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After Login
More information about CRMC, CRMO and CRP
will be shown in Full version of CRMC website
such as
• Study Reference Materials
• Slides of Workshops and Seminars
• Information about External File Archive
• Online test
Study Reference Materials
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CRMO SOPs
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CRMO Standard Operating Procedure (SOP)
•
Planning and
Research
Personnel
Emergencies
Facilities and
investigational
product
•
Processes and
documentation
Ethics &
Regulatory
CRMO harmonizes and develops
research-related SOPs applicable
to all disciplines which can be
modified to meet specific needs
of the disciplines with approval
by department/unit heads and
submitted to CRMO for record.
(CRMO-SOP-001 3.1.1)
Clinical Research Unit should
define the operational
procedures (SOPs) that they
need for conducting clinical
research taking into
consideration institutional
policies and guidelines. (CRMOSOP-001 3.1.2, 3.9)
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Two important references
ICH Guideline for GCP, 1996
(http://www.ich.org/fileadmin/Public_Web_S
ite/ICH_Products/Guidelines/Efficacy/E6_R1/
Step4/E6_R1__Guideline.pdf)
Clinical Research Management and
Compliance at Study Sites - HAHO 2010
(http://www.ha.org.hk/ho/research_ethics/ha
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_handbook.pdf)
CRMO SOPs and attachments
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CRMO SOPs and attachments- Cont’
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2
3
1
You can download a complete SOP (pdf file) from this column
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This is the updated version no. of particular SOP
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You can download the attachment(s) from this column
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4
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Slides of the training video (an abstract of particular SOP) can be downloaded for
revision.
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CRMO SOP online training video
Online training video/ 進入培訓視頻/ 进入培
训视频
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After clicking “Full Version” of column
training video is opened.
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, read the pop-up message and press “OK”, a
CRMO SOP online training video- Cont’
Subtitle
Mute/ Unmute the
audio-guidance
Pause the video
The training video provides audio- guidance and subtitle. You can mute/ unmute the audioguidance and/or pause the video if needed.
CRMO SOP - Quiz
When the video is finished, press “OK” on the pop-up message and proceed to the quiz.
CRMO SOP - Quiz
Fail
If ALL answer(s) is/ are incorrect, you can
press “OK” of the pop-up message and
retake the quiz until ALL question(s) is/ are
answered correctly.
Pass
Submit the correct answer(s) of the
multiple choice question(s).
CRMO SOP - Training Log
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• If ALL answer(s) is/ are correct, you pass the quiz. The date of completion shown on
column 6 will be updated automatically.
• You can revise the training video even you pass the quiz.
The “Completed Date” only shows the last date of completion.
• You can download the latest SOP online training log for your
record
*
CRMO SOPs and attachments
For web-coordinator
only: Overview the
participation rate of
SOP online training
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For Each Research Unit…
Only for your own Unit
o Default: Read-only
o Please decide the person for
Read-Write
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Team List of each Unit
Team members will receive
login ID and password once
their names are added in the
team list by web-coordinator
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Study List* of each Unit (Initiation Form)
*For interventional studies only
•
For PWH:
– Most study information is input by CRMO after HCE approval (for 2014 onwards)
– Email alert to web coordinator every month to
• Complete & update study list
• Check the validity of the team list
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Study List* of each Unit (Initiation Form)
Fill by web coordinator
Update if needed
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Study List* of each Unit (Completion Form)
*
*
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Reports of Study List of each Unit
4 types of reports:
• Ongoing Studies
• Not-Yet Started Studies
• Completed Studies (Sorted by “Year”)
• New Studies (Sorted by “Year”)
Study Unit
Total Number of Ongoing Studies
XXXXX
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Total
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Study ID
Displayed items can
be selected according
to users’ preference
Study Title
PI Name
001
ABC study part 1
Dr. Peter PANG
002
ABC study part 2
Dr. Peter PANG
003
ABC study part 3
004
ABC study part 4
Report can be exported to excel
Dr. Peter PANG
Dr. Peter PANG
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Reports of Study List of each Unit
• New Studies (Sorted by “Year”)
• Completed Studies (Sorted by “Year”)
• Not Empty = Total no. of studies completed in 2008-Date of Report generation (e.g. 2015)
• Particular year
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Training Log of each Unit
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Training Log of each Unit
Audit Trail
Download training certificate
Delete training record
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SOP of each Unit
Download SOP
Operate by Webcoordinator only
Move to archive
Delete record
Modification History
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Thank you!
And we always welcome your valuable
comments!
Contact:
CRMO: crmo@cuhk.edu.hk / ext. 4276
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