EMCRF New Business Application Form

Your details

Investigator’s Name

Job title

Work email

Work phone

Department

PID (if known)

Nominated Study Contact who will assist with study set-up

Name

Email

Describe your role in the study

Please tick one

Chief Investigator

Principal Investigator

Other

Other (details)

Professional Background

Medically Qualified

Nurse

Allied Health Professional

Other healthcare professional

Not a healthcare professional

Please detail

Main Employer

Oxford University

OUH Trust

Oxford Health Trust

Other

Specify employer

Honorary contracts

Oxford University

OUH Trust

Oxford Health Trust

Other

Specify contract

Principal Investigator’s Speciality

Please tick all that apply

VACCINES

DIABETES ENDOCRINE & METABOLISM

GASTROENTEROLOGY

INFECTIOUS DISEASES

NEUROSCIENCES

MENTAL HEALTH

RESPIRATORY

RHEUMATOLOGY

Other

Other (please specify)

PI Experience

No research experience

No previous clinical studies in NHS

No previous studies in the CRF

Adequate training and experience to support this study

If you selected 'other' please use this space to give more detail

Your study

Full Research Title:

What is the name of the study, how will it commonly be referred to?

Expected sample size

Protocol status

Please tick one

Early draft

Final, awaiting approvals

Final, fully approved

Close to final

REC approval required?

Yes

No

Planned start date in CRF:

/ /

End date of CRF Activity (approx)

/ /

Or

NK/NA

Are there any deadlines or constraints the EMCRF review need to consider?

We will do our best to work within these timelines but this may not always be possible

Please give details of the studies independent peer review status below

Please tick one

No Peer Review

Peer review will be completed as part of funding application

Peer review completed & attached

Other (please provide details below)

Please provide details

Organisational and funding Details

Funding status

Please tick one

Expression of Interest

Preparing application

Fully funded

Other or part funded (specify):

Main Funding sources

Please tick one

DHSC/NIHR

Research Charity

Research Council

Other non-commercial

Industry Collaborative

Fully Industry

Other

Other funding sources

DHSC/NIHR

Research Charity

Research Council

Other non-commercial

Industry Collaborative

Fully Industry

Other

Please provide details

Sponsorship

Tick all that apply

OUH

Oxford University

Oxford Health

Industry

Other sponsorship

Are you working with a CTU on this study?

Yes

No

Unsure

If yes, give CTU name & contact details

UKCRF Health Category related to study

Please tick primary category

Other (please provide details)

Collaboration and cross department working

Please indicate if you are collaborating with any other specialities on this study

Tick all that apply

VACCINES

NEUROSCIENCES

DIABETES ENDOCRINE & METABOLISM

MENTAL HEALTH

GASTROENTEROLOGY

RESPIRATORY

INFECTIOUS DISEASES

RHEUMATOLOGY

Others (please specify)

Study Interventions

Primary Intervention

Other (please specify)

Please specify

Secondary Intervention

Other

Please specify

Phase

First in Human

Phase Ia

Phase Ib

Phase II

Phase III

UK/NA

Purpose of Study

Drug Development

Diagnostics

Changing care pathway

Medical devices/healthcare technologies

Repurposing of drugs

Service delivery

Software/Platform/eHealth

Other

please specify

Is this a Clinical Trial of Investigational Medicinal Product (CTIMP) needing MHRA Clinical Trials Authorisation?

Yes

No

Unsure

What is the current IMP manufacturing/ import status?

Not yet manufactured

Being manufactured

Released

Received by pharmacy

UK/NA

Other, provide details

Who is supplying the IMP?

Is the project an Advanced Therapy Investigation Medicinal Product (ATIMP) or GMO?

ATIMP

GMO

Neither

Unsure

Is the project a Clinical Trial of a Medical Device?

Yes

No

Unsure

Is the project a Human Challenge study?

Yes

No

Unsure

Is this a randomised trial?

Yes

No

Other

If choose other please detail.

Details of Participant Group

Adults lacking capacity/or with

Patients

Health volunteers with chronic conditions

Health Volunteers

Complex or specialist needs

Your Study

EMCRF will work with your team to deliver the study – details will be finalised during set up.

Medical Cover in EMCRF: All studies must have a medically qualified person who has agreed to be responsible for ensuring that immediate medical assistance is available for participants during their visits to the CRF. Please ensure this issue is discussed with the CRF.

Will you be able to allocate a named person to provide medical cover for EMCRF visits?

Yes

No

Unsure

Do you have Research Nurse (RN) support from within your department or the Network to cover CRF activity?

Yes

No

Unsure

If YES please give name

Name and Email

CRF Activities

What activities will be undertaken in the CRF?

Tick all that apply

Informed consent

Screening

Recruitment/ enrolment

Intervention/procedure

Follow up

Sample Processing

Other

Other (Please provide details)

Study visits

Outside core hours

Outreach/Lone Working/home Visit

Outpatient visits within core working hours

Other - please provide details below Free text – 50 words

Clinical resources and research support

Please select which EMCRF resources you require

Tick all that apply

Patient bed/recliner in 4-bedded bay

Endoscopy room

Treatment room

Consulting room

Lab processing

In-patient room (for overnight stay)

Early Pharmacy team input

Study set-up support

Other - please provide details below

Free text – 50 words

Do you require additional CRF Core staff support to cover the study visits? E.g: Research Nurse

Yes

No

Unsure

Study specific equipment

Is there any study specific equipment required to be used or stored in EMCRF?

Please note – a separate Risk Assessment and procurement process will be completed for any equipment coming into the facility. Training, size, storage, and post-study arrangements will need to be considered.

Yes

No

Unsure

IF yes, please provide details

100 word

Patient & Public Involvement (PPI)

What PPI has there been in the development of your study/or you are planning to do?

100 words

NIHR Resources

Do you have a PPI representative in your trial team?

Yes

No

Will your study utilise other NIHR resources?

Yes

No

Unsure

If yes, please indicate which below and details of resource (name, location)

NIHR BRC

NIHR Local Clinical Research Network

Other NIHR Clinical Research Facilities (if multicentre study)

Other – please provide details

Details

Have you completed the OUH NHS Trust R&D Feasibility Questionnaire?

Please choose one.

Yes

No

Please have the following documentation ready to submit on request:

2-page CV from Applicant (PI)
Proposal/Protocol/Synopsis Document

If available:

Peer review of study proposal/protocol
Investigator Brochure/SmPC For CTIMPs/ATIMPs
Clinical Investigation Plan For Device Trials
Specialist Protocols For Lab processing, procedures, pharmacy stores etc

Thank you, the EMCRF team will contact you within the next 5 days.

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EMCRF New Business Application Form