Application for Access to Tissue Samples and
Clinical Data Collected During ICON7 for
Translational Research Purposes
v3.0_23rd June 2014
Date of Submission:
Office Use only:
Application [Insert number]: [Insert name of main applicant]
Review date
DecisionApprove/ reject
1) TR Subgroup
2) Trial Steering Committee (TSC)
Date of final approval:-
Please return application form to;
Emma Kent
ICON7 Trial Manager
MRC Clinical Trials Unit at UCL
Institute of Clinical Trials & Methodology
Aviation House
125 Kingsway
London WC2B 6NH
Email: e.kent@ucl.ac.uk
Phone: +44 (0)207 670 4857
Page 1 of 13
MRC Clinical Trials Unit, Aviation House, 125 Kingsway, London WC2B 6NH
Tel: +44 (0)207 670 4857 Fax: +44 (0)207 670 4818
Information for Researchers
This form allows you to apply for access to tissue samples (formalin-fixed paraffin-embedded tumour, peripheral
blood DNA, plasma and serum) that have been collected prospectively during ICON7 for the conduct of
translational research. Before submitting a full application we encourage you to discuss your potential project
with the translational research lead for ICON7;
Professor Gordon Jayson
Dept of Medical Oncology,
Christie Hospital,
Manchester,
M20 4BX,
United Kingdom
Tel ; +44 (0)161 446 3606
Fax ; +44 (0)161 446 3461
Gordon.Jayson2@christie.nhs.uk
Alongside the samples, access to clinical data is likely to be required. The MRC will consider different models of
collaboration for the combined analysis of sample and trial data including: analyses by MRC CTU statisticians;
analysis by statisticians affiliated with researchers; or a combination of the two. Whichever model is chosen, an
agreed joint statistical analysis plan (SAP) will be required to be approved by the MRC CTU Project Lead. It
should be noted that prior to full publication of the trial results, the clinical dataset will not be released to
researchers for independent analysis. However, combined analysis of sample and trial data by MRC CTU
statisticians in conjunction with researchers can be undertaken before publication provided the appropriate
clinical data are mature. Applicants are encouraged to discuss the proposed model with the MRC Project Lead:
Professor Richard Kaplan
Consultant in Oncology
MRC Clinical Trials Unit
Aviation House
125 Kingsway
London WC2B 6NH
Tel : +44 (0)207 670 4849
Fax : +44 (0)207 670 4818
r.kaplan@ucl.ac.uk
Completing this form
This application form will cover your request for both tissue samples and clinical data. However, contracts will be
drawn up for the release of specimens and clinical data separately. The data will not necessarily be released at
the same time as the samples. The timing of clinical data release will depend on the pre-stated hypotheses
being investigated.
Each section of this form contains guidance on the information to be included. We recommend that you read this
guidance carefully. If you have any questions about completing the form please contact Emma Kent, ICON7 Trial
Manager – e.kent@ucl.ac.uk
Application text (sections 1-9) should be no longer than 6 sides of A4 and should be completed in Arial 10 point
font.
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MRC Clinical Trials Unit, Aviation House, 125 Kingsway, London WC2B 6NH
Tel: +44 (0)207 670 4857 Fax: +44 (0)207 670 4818
Application process
Your application will be reviewed by members of the ICON7 Translational Research Subgroup of the Trial
Management Group (TR Subgroup). If the TR Subgroup does not contain sufficient expertise to assess your
application appropriately, they will seek expert external review. If your application is approved by the TR
Subgroup it will then be reviewed by the independent Trial Steering Committee (TSC). The TSC and TR
subgroup may seek clarification regarding parts of your application or provide feedback indicating how they feel
it could be improved.
The TR Subgroup meets 6 monthly but may be willing to review individual applications between formal meetings.
We anticipate that the full application process would take a maximum of 6 months.
Ethical approval has already been obtained for the use of ICON7 samples in research studies which
involve extracting DNA (genetic material) or other material (such as proteins) from tumour and/or blood
samples for;
1. The detection of markers which focus on the response of ovarian cancer to the protocol
therapies (bevacizumab and carboplatin-paclitaxel).
2. The early detection of disease recurrence.
Projects addressing different research hypotheses may require separate ethical approval or must be
conducted in a human tissue authority (HTA) licensed premises. This is discussed further in section 7 of
this application form.
Following final approval, contracts will be drawn up between the MRC and researchers, and a material transfer
agreement (MTA) will be instated between the University of Leeds and the researchers. Draft contracts are
available which give details of the terms and conditions under which samples and data are released.
The closing date for the first round of applications is Friday 5th December 2014
Cost Recuperation
Investigators will be required to cover all shipping costs (if sections are requested this may include shipping from
a central sectioning lab which will not be Leeds University). We expect investigators to provide courier account
details for shipping arrangements which will be requested on the application form.
Plasma and serum samples will be charged in batches of 100 samples at the following rate:
£330.00 per 100 plasma and/or serum samples
This is a cost recovery figure for the sample retrieval service provided by Leeds University.
Please note that section cutting will be commissioned per project and will therefore incur an additional fee to the
above which will be dependent on the quantity of samples requested. In addition please note that cut sections
may be provided at a later date than other samples.
Please ensure that you have funding in place to cover the cost of all samples requested.
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MRC Clinical Trials Unit, Aviation House, 125 Kingsway, London WC2B 6NH
Tel: +44 (0)207 670 4857 Fax: +44 (0)207 670 4818
Process of applying for the release of data or samples
Project seeking data or samples
Applicant identifies appropriate
lead at MRC CTU and establishes
contact.
Applicant completes ICON7 TR
application form and sends to
MRC CTU, copying in their lead
contact.
Reject
Translational Research subgroup
review application
Agree
Reject
Trial Steering Committee review
(via TSC facilitator)
Agree
MRC lead flags
application with
Finance and Contracts
Dept
Feedback to applicant
If and when required
Revise and resubmit
Appropriate level of agreement
put in place between MRC and
applicant’s employer.
Feedback to applicant
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Data / Samples released at
time agreed
MRC Clinical Trials Unit, Aviation House, 125 Kingsway, London WC2B 6NH
Tel: +44 (0)207 670 4857 Fax: +44 (0)207 670 4818
1 Research Project Title
2 Lead Applicant
Name
Institution
Address
Telephone
Fax
Main
E-mail
Alternate
PA
3 Investigators

List all principal applicant and co-investigators and include: name, mailing address, phone, fax and email.

Attach CV to the end of this application: including relevant experience and publications

Include contact details and letter(s) of support from collaborators
4 Research abstract

Abstracts should not exceed 500 words and should be structured to include (1) background to the proposal; (2) specific aims of the
research; and (3) outline plan of research.
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MRC Clinical Trials Unit, Aviation House, 125 Kingsway, London WC2B 6NH
Tel: +44 (0)207 670 4857 Fax: +44 (0)207 670 4818
5 Detailed description of proposed translational study hypothesis

Please describe the overall aim and underlying hypothesis of the study.

Include detailed background information on the clinical and scientific drivers behind the study hypothesis.

Give details of the methods and assays to be used. Please include information to demonstrate appropriate expertise, quality
control and quality assurance systems. It is anticipated that the proposed research methods will be consistent with recognised
international standards.

Include a summary of the timelines you anticipate working within

Samples are generally released for research purposes only. MRC has prior obligations with Roche and the GCIG Groups with
respect to Intellectual property. Any IP rights that are foreseen should be identified to MRC as soon as possible so that they can
be covered in specific agreements.
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MRC Clinical Trials Unit, Aviation House, 125 Kingsway, London WC2B 6NH
Tel: +44 (0)207 670 4857 Fax: +44 (0)207 670 4818
6 Funding source
Please indicate the anticipated funding source for this research project. Please be aware that samples will only be released once evidence of
adequate funding is provided. Specific issues such as equipment, staffing, and running expenses should be addressed. The cost of shipping
samples from the ICON7 sample bank in Leeds, UK to the researcher’s laboratory needs to be borne by the applicant. An estimate of this
cost can be provided on request.
7 Assessment of requirement for additional Ethics Committee approval
Ethical approval has already been obtained for the use of ICON7 samples in research studies which involve extracting DNA (genetic
material) or other material (such as proteins) from tumour and/or blood samples for;
1.
The detection of markers which focus on the response of ovarian cancer to the protocol therapies (bevacizumab and carboplatinpaclitaxel).
2.
The early detection of disease recurrence.
Projects addressing different research hypotheses may require separate ethical approval. Further approval should be considered for any
studies involving gene sequencing.

Please indicate if you consider ethical approval to be required externally or if it will fall under the broad coverage of the ICON7
protocol and therefore requires approval by the ICON 7 TR subgroup and TSC only.

If external approval is deemed necessary, please provide details of where and when you intend to submit the proposed project for
ethical review.

Is the existing ICON7 patient consent form adequate to cover the work in the proposed project?
Please note that it may be necessary to discuss your application with the international leaders of the GCIG groups to ensure that your
proposal is compatible with standard research practice in the relevant member’s country.
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MRC Clinical Trials Unit, Aviation House, 125 Kingsway, London WC2B 6NH
Tel: +44 (0)207 670 4857 Fax: +44 (0)207 670 4818
8 Samples required

The ICON7 bio-repository contains formalin fixed tumour, peripheral blood DNA, plasma and serum.

Please give details of which samples, how many and how much of each sample (volume of plasma, number of sections etc) are
required for proposed project.

Please provide information on when samples will be required and under what conditions they will be stored at your site.

How has the sample size for this translational research project been calculated? Include background evidence to support the
expected event-rate for the biological endpoints under investigation e.g. allelic frequencies, distribution of expression of RNA etc.
as appropriate. Also refer to the expected clinical event-rate in the associated trial(s) in relation to the translational data sample
size determination.

Please give contact details of translational study biostatistician if appropriate.
Please note that section cutting will be commissioned per project and may therefore be provided at a later date than other
samples.
9 Link to clinical data

What clinical data will be required for the proposed project? Include a summary of the variables requested.

Describe in detail how the translational data will be linked and integrated with the clinical data from the ICON7 trial, and provide the
framework for the analysis of the combined data (analysis by MRC statistician, analysis by statisticians affiliated with the
researcher, or a combination of the 2). Include whether the personnel resources needed for performing the analysis are available.

Describe what discussion has been entered into with the project lead.
Please be aware that the clinical dataset for the trial will not be released to investigators before full publication of the clinical results.
However, combined analysis of sample and trial data by MRC CTU statisticians in conjunction with researchers can be undertaken before
publication provided appropriate clinical data are mature.
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MRC Clinical Trials Unit, Aviation House, 125 Kingsway, London WC2B 6NH
Tel: +44 (0)207 670 4857 Fax: +44 (0)207 670 4818
10 Evidence of peer review
Please indicate what peer review the proposed project has undergone. Include details of those performing the review and what
recommendations they made. Indicate whether you have addressed the recommendations, and if not give a justification for this.
11 Publication Policy and Intellectual property rights

How and where do you plan to present and publish the results of this project?

It is expected that MRC CTU staff would be acknowledged or co-authors of projects using trial data. What are the plans for this
project? See condition 1 overleaf.

Data will need to be published in an Open Access format according to MRC guidelines, unless there are extenuating
circumstances, and paid for by the Applicant.

The data remain under MRC custodianship. Specify what will be the proposed intellectual property rights over the outputs and
deliverables. IPR will be finalised in a formal agreement.
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MRC Clinical Trials Unit, Aviation House, 125 Kingsway, London WC2B 6NH
Tel: +44 (0)207 670 4857 Fax: +44 (0)207 670 4818
Page 10 of 13
MRC Clinical Trials Unit, Aviation House, 125 Kingsway, London WC2B 6NH
Tel: +44 (0)207 670 4857 Fax: +44 (0)207 670 4818
GENERAL CONDITIONS – FOR INFORMATION, NOT EXHAUSTIVE. THIS IS AN
INDICATION OF THE TERMS AND CONDITIONS THAT WILL MAKE UP THE CONTRACTS
FOR BOTH SPECIMEN AND DATA RELEASE
Conditions under which data and samples collected as part of an MRC CTU clinical trial can be shared with
external groups for research purposes.
1. The applicant must keep the link person at the MRC CTU informed of the development of the project and
must provide any draft publication for review by the TR subgroup and Roche before it is used in any type
of public presentation or submitted for publication. The ICON7 trial should be referenced and the link
person and up to three GCIG investigators identified by the ICON7 TR subgroup should be included as
authors if the publication includes linked clinical data. A reprint of the resulting publication should be
provided to the MRC CTU as soon as available.
2. The research project must conform to relevant ethics and HTA research governance requirements.
3. Data and samples will only be released once approval has been obtained from the scientific lead for the
trial at the MRC CTU, the Head of the Cancer Group at the MRC CTU, and the TR Subgroup. A decision on
approval will be based on the review of the detailed description of the project and the feasibility of the
data and sample extraction/transfer.
4. The data transferred are confidential, data and samples must be stored in a secure location, must not
serve for any other purposes than those specified in the application and must not be discussed outside of
the working group for the project.
5. Upon completion of the project or publication of the results, a copy of the database must be sent to CTU,
and all copies of the database must be archived securely.
6. The MRC CTU is the custodian of all the samples and trial data and holds the Intellectual Property Rights.
Any change from this position must be clearly stated in section 1 above and will be covered in detail in
the associated contract.
7. Additional conditions on sample storage and return may be required
8. A separate contract must be signed for the release of samples, and the release of clinical data.
MRC CTU staff involved
Link person:
Others involved:
Applicant’s Name:
Application’s signature:
Date:
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MRC Clinical Trials Unit, Aviation House, 125 Kingsway, London WC2B 6NH
Tel: +44 (0)207 670 4857 Fax: +44 (0)207 670 4818
Office Use only:
Comments

Focus on confidentiality, acknowledgement, overlap with other work and scientific validity

TR subgroup members only- Please comment on whether the research proposed in this application would meet generally
accepted laboratory and ethical standards in your country.
TR Subgroup:
Trial Steering Committee:
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MRC Clinical Trials Unit, Aviation House, 125 Kingsway, London WC2B 6NH
Tel: +44 (0)207 670 4857 Fax: +44 (0)207 670 4818
Approval log
Scientific lead for the trial at the MRC CTU:
__________________________________
Signature:
__________________________________
Date:
__________________________________
Email confirmation received:
Head of the Cancer Group at the MRC CTU:
__________________________________
Signature:
__________________________________
Date:
__________________________________
Email confirmation received:
Chair of the TR Subgroup:
__________________________________
Signature:
__________________________________
Date:
__________________________________
Email confirmation received:
Chair of the Trial Steering Committee:
__________________________________
Signature:
__________________________________
Date:
__________________________________
Email confirmation received:
Page 13 of 13
MRC Clinical Trials Unit, Aviation House, 125 Kingsway, London WC2B 6NH
Tel: +44 (0)207 670 4857 Fax: +44 (0)207 670 4818