Hospital Approvals of Clinical Trials-
(towards harmonised approval of multi-
centre clinical trials)
Susan Lennon
Clinical Research Manager 26th January
2012
Understanding the landscape How do hospitals approve multi-centre trials ?
– Annual workload per hospital
– What information is required to achieve hospital
approval ?
– What currently works?
– What are the key challenges?
– Conclusions and areas for further discussion/action
Hospital Approval in the Clinical Trial
Continuum
Process for gathering/assessing
information on hospital approval
• Who is responsible for review and sign off in the
hospitals?
• Interview with 6/9 teaching hospitals prioritised
– so far
• Categorisation of the information received
• Review of the categorised information
High Level Results
Key (High Level Preliminary Results)
Volume
0
10
20
30
40
50
60
70
80
90
100
A B C D E F
Nu
mb
er
of
an
nu
al a
pp
rova
ls
Hospital
Estimated applications/annum/hospital
Key (High Level Preliminary Results)
Types of studies
Number of Hospitals
Pharma/Med Device Sponsored
Investigator led studies 100% 100%
Key (High Level Preliminary Results) Has Hospital/Institution acted as a Sponsor?
0
0.5
1
1.5
2
2.5
3
3.5
4
Yes No
Nu
mb
er
of
Ho
sp
ita
ls
Sponsorship
Key (High Level Preliminary Results)
Average timelines for sign off
0
1
2
3
4
5
6
A B C D E F
We
ek
s
Hospital
Average time to approval
Key (High Level Preliminary Results)
Department responsible for review
– Legal
– Risk Management
– Finance
– Ethics Department
– Special committees
Key (High Level Preliminary Results)
Hospital Specific Forms required?
Hospital Specific Forms Required
Yes
No
50% 50%
Key (High Level Preliminary Results)
Data Reviewed
– IMB approval (if required)- 100%
– REC Approval- 100%
– Protocol- procedures- 50%
– Indemnity/Insurance-
– Consistently look for advice – 33%
– Sometime seek advice – 16.5%
– Rarely seek advice- 33%
– Don’t know – 16.5%
– Clinical Trial Agreement- 100%
– Data Protection – 50%
– Finances – 50%
Key (High Level Preliminary Results) Routinely check for use of hospital
Resources
0
0.5
1
1.5
2
2.5
3
Yes No
Nu
mb
er
of
Ho
sp
ita
ls
Key (High Level Preliminary Results) Main objective of review process
• Protect hospital – 1
• Protect PI and hospital – 1
• Protect hospital and patients – 1
• Protect hospital, patients, PI - 3
Key (High Level Preliminary Results)
Communication
50% 50%
Routine Communication with personnel in other hospitals with this responsibility ?
Yes
No
Key (High Level Preliminary Results)
What works well?
• HSE Indemnity form
Key (High Level Preliminary Results)
Main challenges
– Differing Clinical Trial Agreements
– Indemnity/Insurance
– Uncertainty
– lack of shared understanding
– Differing support documentation
DOHC Guidelines 2007
2.2 Site Specific Assessment The EU Directive and the Clinical Trials Regulations, 2004- only one ethical review per state
The site specific assessment (SSA) form (Form 3) must also be completed and submitted
with the standard application form and supporting documentation in order for an application
to be valid.
In the case of a single-centre clinical trial, SSA form completed and the “Declaration of the
Chief Investigator/Investigator” should be signed by the Investigator at that site.
In the case of a multi-centre clinical trial, the SSA form should be completed and signed by
the Investigator at each site in Ireland, (i.e. one for each site).
The Investigator at each site must forward the SSA form to the Chief Investigator of the clinical
trial. The Chief Investigator should submit all of the SSA forms, together with all other
supporting documentation.
An application for an ethical review will not be valid unless the SSA form for each of the
proposed sites has been submitted.
DOHC Guidelines 2007
2.3 Seeking Permission from the Site to conduct a
clinical trial The Investigator at each site responsible for obtaining permission for the clinical
trial to be conducted at his or her specific site from the site CEO or person acting on
his or her behalf.
It is the view of the Supervisory Body that the SSA form contains all the
necessary information required by the CEO or person acting on his/her behalf
to decide whether to give permission for the clinical trial to be conducted at
the site.
The CEO or person acting on his/her behalf is only being asked to decide
whether the site has sufficient facilities, personnel and resources to conduct
the particular clinical trial at the site.
Where aspects of the clinical trial conflict with the particular ethos of the site, the
CEO or person acting on his/her behalf cannot request any changes be made to the
clinical trial. He or she can only grant or refuse permission for the clinical trial to
take place at that site.
DOHC Guidelines 2.3- continued
If the CEO or person acting on his/her behalf is satisfied that the site is in a
position to conduct the clinical trial then he or she should sign the
Declaration of CEO or person acting on behalf of CEO” and return it to the
site Investigator (Chief Investigator in the case of a single-centre clinical
trial). In the case of a multi-centre clinical trial, each site Investigator must
forward the SSA form signed by the CEO or a person acting on his/her
behalf to the Chief Investigator who must then forward them to the REC for
its file.
A clinical trial cannot commence at a site until the CEO or a
responsible person acting on his/her behalf at that site, signs the
“Declaration of CEO/ person acting on behalf of CEO” at the end of the
SSA form. This is the case irrespective of whether the REC gives a
favourable opinion on the trial for that site.
DOHC Guidelines 2.3- continued
The timelines set out in the Clinical Trial Regulations do not extend to the
CEO or to the person acting on his/her behalf and the REC does not need
the SSA Form (Form 3) with the box entitled “Declaration of CEO/ person
acting on behalf of CEO” completed, in order for an application for ethical
review to be validated.
However, in keeping with the spirit of the Directive and the Regulations,
CEOs and persons acting on their behalf, are strongly urged to make a
decision and to complete the SSA form as early as possible.
Potential areas for further
discussion/action – Agreed defined Checklist and process for
SSA/Hospital Approval
– Are any supporting documents required ? – if so
– Definition of the requirements of each support document
– Fit for Purpose
– Not a regulatory/ethics review
– Harmonised Clinical Trial Agreement Template?
– Elements e.g. Indemnity
– Forum for support and sharing of “best practice”
Thank you for your attention
www.MolecularMedicineIreland.ie
MMI – Enabling Clinical & Translational Research