Submit an online application

NIHR CRN Study reference:
(for network use)

Section A

Information provided in this section will be disclosed only under a formal non-disclosure agreement.

Protocol identification

(corresponds to IRAS, NHS and R&D form sections A1 and A5)

A1 *
Full protocol title (QA1)

A2
Protocol version and date (QA5-1)

A3
Sponsor protocol number/reference (QA5-1)

A4 Trial registration number(s) (if known, QA5-1)

EudraCT

ClinicalTrials.gov: NCT

Current Controlled Trials: ISRCTN

Insert the number that is used as the unique registration identifier for this study

Sponsorship and funding

A5
Name of research sponsor (corresponds to NHS R&D form QA64)

A6
Name of research funder (if different from above)

A7
Name of chief investigator (NHS R&D form QA3)

Product information

(corresponds to NHS R&D form Part B)

A8 *
Name(s) and class(es) of investigational product

A9
Who is responsible for development of the product?

Data analysis

A10
Who was responsible for the statistical input to the trial design?

A11 *
Who will own the dataset? (NHS R&D form QA43)

A12 *
Who will carry out the statistical analysis of the data? (NHS R&D form QA42)?

A13
Does the protocol contain a pre-specified interim analysis plan?

yes
no

A14
Who will review any interim analysis of the outcome measures?

Protocol review (corresponds to NHS R&D form QA55 & A57)

Please provide as much detail as possible on any internal or external protocol review processes undertaken. Please note this information will be reviewed by the adoption panel as part of the assessment of the adoption criteria.

A15 *
Where individuals or organisations external to your company were consulted in the development or design of the current protocol (eg safety review, scientific critique, statistical advice), please give details, including names of individuals.

A16 *
Where regulatory authorities have been approached for scientific advice in protocol development (ie prior to application for clinical trial authorisation), please give details, including name of the regulatory authority and any issues raised.

A17 *
Please outline any internal protocol review processes which were undertaken.

Studies in neonates, children and/or adolescents

A18 *
Will the trial involve neonates, children and/or adolescents?

no
yes

If yes, has a paediatric investigation plan been developed? *

no
yes

Details of sites already approached

Please list any UK investigators (including host organisation details) that you have already approached, providing details of whether they have been FORMALLY SELECTED, are currently UNDERGOING FEASIBILITY, or have been REJECTED.
Please present this information as a tabular list in the box below providing PI name, NHS trust/GP Practice details and status for each investigator approached.

A19 PI name, NHS trust/GP practice details and status for each investigator approached. *

Company contact

A20

Please provide details of a company representative who may be contacted for discussion or more detailed clarification of the details provided on this form

Name *

Telephone *

Email address *

Mobile *

Section B

The information in this section should be treated as confidential. However, it may be distributed to third parties for the purposes of assessing the study without the need for a formal confidentiality or non-disclosure agreement.

Trial design

B1 *
Phase of development (if applicable)

I
II
III
IV

B2 *
What is the care setting (eg primary, secondary, community) for: (a) the recruitment of patients (b) the treatment of recruited patients Please answer (a) and (b) in the box.

B3 *
Is the study multinational?

no
yes

B4 *
What is the target recruitment

the UK
the research network
worldwide
EU

The following questions relate to the minimum recruitment target for individual sites

B5 *
If applicable, how many UK subjects under 18 years of age are sought?

B6 *
If worldwide recruitment applies, is this competitive?

no
yes
N/A

B7 *
What is the maximum number of study sites being sought in the UK?

B8 Study timelines

Expected start of recruitment in UK *

Expected end of recruitment in UK *

Duration of study treatment *

B9 *
Disease indication / target patient population

B10 *
Route of study drug (if applicable)

B11 *
Please briefly describe the randomisation strategy (eg number of treatment groups; ratio of treatment group number; which, if any treatment groups are placebo controls)

B12 *
Primary objective(s) (corresponds to NHS R&D form QA10)

B13 *
Secondary objective(s) (corresponds to NHS R&D form QA11)

B14 *
Full inclusion criteria (corresponds to NHS R&D form QA17)

B15 *
Full exclusion criteria (corresponds to NHS R&D form QA18)

B16
Can the protocol be modified at the current time?

yes
no

B17 *
Please provide a specific description to the adoption panel of the way the trial (on its own or as a component of a development programme) is expected to lead to a possible clinical benefit for NHS patients.

Site research resources

As a condition of adoption, the NIHR CRN requires completion of the Industry Costing Template (available to download from the NIHR CRN website). This tool supports a transparent and consistent method of costing trial activities and assessments to support rapid negotiation and agreement at site.

B18 *
After completing this template, please indicate the per patient fee available to participating trusts for this study.

B19 *
Please provide details of any specialist facilities required for the study which might impact on site feasibility (eg specialist imaging facilities or services; specialist pathology facilities or services; aseptic pharmacy or other specific pharmacy services; pharmacokinetic sampling).

B20 *
Please provide details of any specialist expertise or training required for the study which might impact on site feasibility eg administration of psychological tests.

B21
Is a full schedule of investigations available?

no
yes

If yes, please forward a stand alone copy of the study schedule with this form, ensuring that any sensitive information is removed.

B22 *
Date form completed

* Denotes required field.

Submit an online application

The form below is divided into two main sections.

Notes on completion of the form

Industry trials adoption process and feasibility assessment

Section A

Protocol identification

Sponsorship and funding

Product information

Data analysis

Protocol review (corresponds to NHS R&D form QA55 & A57)

Studies in neonates, children and/or adolescents

Details of sites already approached

Company contact

Section B

Trial design

The following questions relate to the minimum recruitment target for individual sites

Site research resources