Attachment 6C University of Hong Kong IRB approval

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lnstitutional Review Board of the University of Hong Kong/
HospitalAuthority Hong Kong West Cluster (HKU/HA HKW IRB)
Address:Rm90i,AdministrationBlock,QVIHTel

2255392322554086 Fax22554135

Prof. YL Kwong
Medicine
Queen Mary Hospital
29-Aug-14

Dear

Prof. Kwong,

IRB Reference Number: UW 11-400
The HKU/HA HKW IRB is authorized by a joint agreement of the University of Hong Kong and
Hospital Authority Hong Kong West Cluster to review and monitor clinical research. lt serves to
ensure that research complies with the Declaration of Helsinki and acts in accordance to ICH GCP
guidelines, local regulations and Hospital Authority and the University policies.
ln accordance with our standard operating procedures, we have duly performed ethics and scientific
review of your application/submission. We hereby write to inform you that your application/
submission has been approved by an expedited process with details shown below.

Protocol title

:

Study site(s)

:
:
:
:

Queen Mary Hospital

:

Every 12 months from the date of initial approval and during the the
period of the study

IRB reviewer
Document(s) approved

Regular Progress
Report(s) Required

A multi-center international hospital-based case-control study of
lymphoma in Asia (Asialymph)
Dr. Brian Lang, Deputy Chairman of the HKU/HA HKW IRB
01. Protocol Amendment Application Form dated 7 August 2014
02. Supplementary Document - Extension of Asialymph to include
cases with myeloid neoplasms

You, being the principal investigator of the study at your study site, are reminded to comply with
our requirements and to maintain communication with us during the period of the study by
undertaking the principal investigator's responsibilities including (but not limited to):

.

if the study is an industry-sponsored clinical study, submitting to us a copy of the fully executed indemnity
agreement satisfying the Hospital Authority's requirement prior to commencement of the study (if it has not
been submitted yet);

.

observing and complying with all applicable requirements under our standard operating procedure ("HKU/HA
HKW IRB SOP"), the Declaration of Helsinki and the ICH GCP (if applicable)

.

submitting regular progress report(s) at the required intervals (as specified above) in accordance with the
requirements in the IRB SOP;

.

not implementing any amendmenVchange to any approved study documenVmaterial without our written
approval, except where necessary to eliminate any immediate hazard to the subjects or if an
amendmeni/change is only of an administrative or logistical nature;
notifying us of any new information that may adversely affect the rights, safety or well-being of the subjects or
the proper conduct of the study;

.
.
.
.

reporting any deviation from the study protocol or compliance incident that has occurred during the study and
may adversely affect the rights, safety or well-being of any subject in accordance with the requirements in
the IRB SOP;
submitting safety reports on all SAEs observed at your study site or SUSARs reported from outside your study
site in accordance with the requirements in the IRB SOP; and

submitting a final report in accordancewith the requirements in the IRB SOP upon completion ortermination of
the study at your study site.

UW

11-400 29-08-2014

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ln addition to the above, you are also reminded to observe and comply with other applicable
regulatory and management requirements including (but not limited to):

.
.
.

if required by Hong Kong laws or regulations, obtaining a certificate for clinical trial through the Hong Kong
Department of Health and complying with the associated requirements; and
obtaining the necessary mnsent from the management of your institution/department in accordance with the
requirements of your institution/department; and

obtaining prior approval before commencing the study from the appropriate head(s) of the study site (e.9. Head

/ COS / Nurse Manager / Department Manager etc) with regards to the use of facilities and subject recruitment
logistics/arrangem ent.

Yours sincerely,

dn'fu
Mr. Chris Yip
HKU/HA HKW IRB Secretary

UW

11-400 29-08-2014

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