| Q. |
What is the Sri Lanka Clinical Trials Registry? |
| A. |
The Sri Lanka Clinical Trials Registry (SLCTR)
is a Registry for clinical trials involving human subjects,
conducted in Sri Lanka or overseas. It is a not-for-profit Registry,
with free and open access to researchers, clinicians, and the
general public. |
|
| Q. |
What is a Clinical Trial? |
| A. |
A Clinical Trial is any research that studies
the effects of a health care intervention in human subjects
(patients or healthy volunteers). A ‘ health care intervention’
can be a drug, vaccine, surgical treatment, device, behavioural
modification, preventive measure or a process of care change,
that would lead to a change in a health-related outcome. All
clinical trials need prospective registration in a Clinical
Trial Registry. |
|
| Q. |
What is a Clinical Trials Registry? |
| A. |
A Clinical Trials Registry is a central repository of key
information about clinical trials. |
|
| Q. |
Why register clinical trials? |
| A. |
Prospective trial registration certainly has
many benefits to scientists, clinicians, health care planners
and the general public. It would, hopefully, lead to publication
of all trials conducted, and minimise non-publication of trials
with negative results or inconclusive results. Dissemination
of the results of all trials is important, as the scientific
community needs to be aware of findings from clinical trials,
and patients and volunteers participating in trials need to
be reassured that their participation would lead to advancement
of scientific knowledge. Awareness of planned or on-going trials
among the research community would certainly help avoid duplication
of trials, minimising wastage of research effort and funds.
Prospective registration would also facilitate multi-centre
participation in clinical trials.
Prospective registration of all clinical trials involving human
subjects is now a requirement for trial publication in International
Biomedical Journals. |
|
| Q. |
Who manages the SLCTR? |
| A. |
The SLCTR is a joint initiative of the Sri
Lanka Medical Association (SLMA)
and the Ceylon Medical Journal (CMJ). The SLMA is the premier professional
medical association in Sri Lanka, which brings together medical
practitioners of all branches of medicine. It is the oldest
medical organization in Ausralasia, with a proud history dating
back to 1887. The CMJ is the official quarterly journal of the
SLMA.
The
SLCTR is managed by an advisory group appointed by the Sri Lanka
Medical Association (The SLCTR Committee).
|
|
| Q. |
Does the SLCTR meet international requirements for a Trial
Registry? |
| A. |
Yes, the SLCTR complies with all the requirements
specified by the International Clinical Trials Registry Platform
(ICTRP) of the World Health Organisation and the International
Committee of Medical Journal Editors (ICMJE). |
|
| Q. |
Who can access the SLCTR? |
| A. |
The SLCTR is an internet-based registry, with
worldwide free and open access to researchers, clinicians, and
the general public. |
|
| Q. |
Who can register a clinical trial with the SLCTR? |
| A. |
Any investigator, from Sri Lanka or overseas,
can register a clinical trial with the SLCTR. The responsibility
for registering a trial lies with the principal investigator
or principal sponsor of the trial. For multi-centre trials,
the lead principal investigator or lead sponsor should take
responsibility for registration. |
|
| Q. |
How can I register a trial with the SLCTR? |
| A. |
Trial registration can be done by completing
the Application Form on-line.
All data fields must be completed by the investigator. It is
assumed that all trials would have obtained approval from a
recognized ethics review committee before enrolment of subjects.
The investigator will be notified
by an e-mail when the application has been approved for registration,
and a unique trial identifier number will be issued. |
|
| Q. |
Is there a trial registration fee? |
| A. |
An application processing fee for trial registration
is levied by the Sri Lanka Clinical Trials Registry to meet
administrative costs.
Processing
fees for trials conducted in Sri Lanka are Rs. 10,000.00 for
trials sponsored by the pharmaceuticals industry, and Rs. 5000.00
for trials without industry support. Fees can be paid to the
SLMA Office by cash, or by cheque in favour of the “Sri Lanka
Medical Association”. Processing fee for trials conducted overseas
will be USD 100.00, payable by bank draft to the “Sri Lanka
Medical Association”. |
|
| Q. |
Who is responsible for the accuracy of the data regarding
a clinical trial? |
| A. |
The responsibility for the accuracy of the data
regarding any clinical trial lies with the principal investigator
or the principal sponsor who provides the trial data. |
|
| Q. |
Will I need to update trial information? |
| A. |
All investigators are expected to update trial
information at regular intervals. They are required to provide
a brief progress report at six months, one year, and every year
thereafter until trial completion.
Investigators
are expected to inform the SLCTR Office of any changes to the
trial protocol. These will be displayed in the trial registration
data set via a separate link. |
|
| Q. |
How can I find more details about the SLCTR? |
| A. |
You can contact us by e-mail (slctr@sltnet.lk),
by phone (+94 112690212), or by writing to us at the Sri Lanka
Clinical Trials Registry, Sri Lanka Medical Association, No
6, Wijerama Mawatha, Colombo 7. |
