APPLICATION TO USE THE NIHR/WELLCOME TRUST...

ICRF-POL001.05 Application to use the ICRF 16 Sep 2013 of 22

APPLICATION TO USE THE NIHR/WELLCOME TRUST IMPERIAL CLINICAL RESEARCH FACILITY

POLICY

Reference Number ICRF-POL001.05

Author(s): Dr Karen Mosley, ICRF General Manager

Contact Details: [email protected]

Reviewer(s): Vincenzo Libri, Head of Clinical Studies Shokri Othman, Lead Nurse

Date written/revised: 16 Sep 2013

Approved by: Core Management Team

Name, signature and date

Ratified by: Q,H&S Committee

Name, signature and date

Date Policy becomes Live:

26 Sep 2013

Due date for revision: 26 Sep 2015

Target Audience: ICRF CORE STAFF and researchers using the ICRF

Location of Policy: Electronic: Imperal CRF electronic store \SOPs and policies\Policies ICRF Paper: Imperial CRF Master File

Related SOPs and Policies:

Protocol Review Board terms of reference

This is a controlled document. Users may generate copies for training and reference purposes. Imperial CRF staff and Principal Researchers using the facility will be emailed as updates become available but they are responsible for replacing local obsolete copies and ensuring staff are appropriately trained

QA Manager Use Only – This section to be completed in red ink on controlled copies. All other copies are uncontrolled and the user is responsible for ensuring they use the current version.

Controlled copy number

Location

Signature and date

Document version numbering

Version Date Updated by Reason for change

1 February 2009 Karen Mosley New policy

2 April 2010 Karen Mosley Updated to reflect changes in opening hours

3 April 2012 Karen Mosley Move to new facility and introduction of the PRB 4 March 2013 Karen Mosley Changes to application form and CRF name

change

5 July 2013 Karen Mosley Changes to process and application form

mailto:[email protected]


1.0 Definitions Protocol Review Board (PRB) Committee comprising CRF Director, CRF Head of Clinical

Research, CRF General Manager, CRF Lead Nurse, and non-ICRFmembers covering toxicology, clinical pharmacology, pharmacy, safety and medical statistics set up to review all applications to the ICRF

2.0 Policy There are two stages: 1. Initial contact and review 2. Sharing appropriate documentation to enable study set up.

The policy applies to all research admissions to the NIHR/Wellcome Trust Imperial Clinical Research Facility (ICRF). Any standard clinical care required by a participant will remain the responsibility of the relevant team and will be managed through conventional NHS booking processes, unless agreed otherwise.

Stage 1: CRF Approval

All requests to undertake clinical research using the ICRF must be approved by the Protocol Review Board (PRB), consisting of the CRF Director, CRF Head of Clinical Research, CRF General Manager, CRF Lead Nurse, and non-ICRF members covering toxicology, clinical pharmacology, pharmacy, safety and medical statistics. The PRB meets twice monthly and requires the following information: • A copy of the research protocol • Completed ICRF Application Form (Appendix 1). • Completed ICRF Phase 1 committee risk assessment template for Phase I studies. NB Phase I studies will only be reviewed at the second PRB per month • PI and lead researchers’ CVs

An electronic format for each document is required and this should be e-mailed to the ICRF ([email protected]) at least one week before the next PRB meeting.

The project will be assessed according to the: • Scientific value of the question asked • Availability of resources, including access to appropriate numbers of subjects • Existing activity within the CRF

The PI and/or the key trial co-ordinator of the study will be invited to the relevant PRB meeting and will be given the opportunity to introduce their study and discuss their application with the Board. After they leave the meeting room, the PRB will formulate their opinion and the outcome of the discussion/decision will be discussed. The overall risk of the study will be assessed by the PRB and recorded on the application form and the research database and a study contact assigned. After the meeting the application form will be amended and updated to reflect all changes made and to add the risk assessment and study contact name. The application form will be saved to the electronic study folder on the shared drive and marked as ‘post PRB’. This will be signed by the Chair or delegate and the study contact against the date of approval. A letter will be sent to the PI of the study within 5 working days informing them of the board’s decision along with the updated application form and a copy of the User’s Guidelines. The PI should sign the last page of the updated application form and return to the CRF to confirm that they agree with the changes made


PRB outcomes:

Full Approval Approval for a period of 12 months to commence once the study has been given PRB approval. Studies will not be able to go ahead until all regulatory and ethical approvals are in place.

Conditional Approval Study is approved subject to amendments, additional information and financial agreements. Issues raised are brought forward to a subsequent PRB meeting for full reconsideration or approval by Chair’s action.

Deferred The committee is unable to make a decision from the information submitted. Additional information will be requested and/or the investigator invited to attend a subsequent PRB meeting to discuss the project further. If a study is deferred awaiting further information and the PRB committee agree, the study may be approved by Chair’s action in consultation with the Board Committee.

Non- Acceptance The study is not approved to go ahead in the ICRF. The reason(s) for non-acceptance will be notified. The study may go ahead elsewhere in the Trust in line with standard R&D and Research Ethics approvals.

The Protocol Review Board has the right to revoke a PI’s access and use of the ICRF if it is felt that this is an appropriate course of action. This decision would not be taken without exhausting other options and would be fully documented.

Appeals

If an application is not given full approval and the applicants feel they can address the reasons given for this, they can revise their application to use the ICRF accordingly and re-submit. If the applicants feel that the PRB has not accepted the application because there has been a misunderstanding of any aspect of the application, the applicants have the right to appeal the decision. In the first instance the applicants should put their concerns in writing to the CRF Director. The CRF Director will consider the appeal. If the CRF Director accepts the grounds for appeal, it will be re-presented to the Board. Stage 2: Initial Study Set Up Studies can commence when Trust R&D and REC approvals are in place and when the CRF study set-up process is complete. Before studies can commence, PIs will be also be required to produce all documents listed in the CRF Study Application Form and undergo ICRF induction. A mutually agreed start date will be arranged. Each PRB approved study will be allocated to a CRF named person who works as a Study Contact (Appendix 1: Study Contact Roles and Responsibilities). A study initiation meeting will be scheduled between the study team, Study Contact and CRF clinical team assigned to the study, ensuring that all required documents are in place and the trial protocol can accurately translate into practice. All members of the study team will be required to complete all relevant training (including GCP training within the previous two years) to enable studies to be implemented safely and effectively. Investigators will also be expected to comply with GCP requirements and Trust policies, as well as the CRF users’ guidelines and standard operating procedures.


Before a study can start, it is the responsibility of the Principal Investigator or co-investigator to ensure that the ICRF has the following, where applicable:

Documents • An up to date protocol including date and version • Sponsor letter • Imperial CRF risk assessment for Phase I studies • Proof of funding • Patient information sheet, consent form and GP letter including version and date • Other patient materials e.g. contact card, diaries • Copy of REC application and SSI • Copy of approval (favourable opinion) letter from REC • Copy of Trust R&D approval letter • Copies of all GCP certificates, signed CVs and BLS/ILS/ALS certificates (if available) for the research team • Copy of MHRA approval letter • Evidence (email/letter) of approval by Joint Clinical Research Safety Committee as applicable • Other approvals if applicable eg ARSAC • Investigator’s Brochure (for investigational medicinal product (IMP) studies) • Laboratory manual if applicable • Confirmation that the study has been registered on a publicly accessible database e.g. www.clinicaltrials.gov • Confirmation that the study has been registered for inclusion in the NIHR portfolio Other • Study specific SOPS. These must be reviewed by the QA Manager prior to study start. • Study related supplies • Case Report Form (CRF) or appropriate electronic access and training for eCRFs • Specialist equipment not already available in the CRF • Laboratory supplies for sampling • A clear understanding of what the role of the CRF is to be • Training of staff for new procedures • Study Initiation training/visit • Access to a Trial Master File/Site file • Confirmation about who will contact the participant in order to arrange study visits • Clear contact details for all the research team and representatives of the sponsor e.g. monitoring team, emergency and out of hours contact details. • Where required, confirmation of the expenditure code for travel and out of pocket expenses

In addition, all researchers involved in the study must undergo ICRF training (contact [email protected] to arrange training), have a substantive or honorary contract (Licence to Attend) with the Trust and have completed their GCP training. Copies of signed CVs and GCP certificates are required before access to the CRF is granted

http://www.clinicaltrials.gov/



Once the study has started:

Annual Renewals All studies must be reviewed on an annual basis. The renewal form will be sent to the PI/researcher two months before the due date. The form must be completed in full and returned before the end date of the original approval. The request for continuation will be sent to the PRB for review and if successful a renewal letter will be issued. Failure to return the renewal form will mean that the study will be removed from CRF Manager and no further bookings will be taken. The annual renewal form must also be completed for studies that ended within the previous year as they provide the CRF with essential information relating to NIHR metrics. Protocol Amendments Investigators are requested to provide copies of protocol amendments as soon as they have been approved. This must include evidence of REC, MHRA and R&D approval and all supporting documentation. Protocol amendments will be reviewed by the committee when considered necessary, e.g. if changes to the protocol are likely to impact significantly on the patient or the CRF.

Study Completion The End of Study Notification document and final report must be submitted to the PRB once the study is completed. Investigators are also expected to acknowledge the CRF in publications, and inform the CRF of all publications that relate to work facilitated by the CRF, either physically or intellectually. This is critical as our funders will only accept publications acknowledging the NIHR CRF, and this directly impacts on our future funding and therefore your future support. The following statement must be included in all publications:

This article/paper/report presents independent research funded by [name of funder] and carried out at the NIHR/Wellcome Trust Imperial Clinical Research Facility. The views expressed are those of the author(s) and not necessarily those of the (name of funder), the NHS, the NIHR or the Department of Health.

Booking procedure for study subjects Admission request forms must be sent directly to the ICRF to arrange admission. The ICRF is routinely open from 8am to 8pm Monday to Thursday and 8am to 6pm on Fridays; however we may offer extended opening hours if required. Any study requiring a longer admission will have to be discussed with the senior management of the CRF prior to the study being accepted.

Requests for admission will only be accepted if they are presented to the ICRF either electronically (via NHS email only), by fax or by hand on the correct form (Appendix 2). Forms will only be accepted if they are completed and clearly state the following:

• Referring clinicians name • Contact telephone numbers for the participantand referring team • Participants NHS number • Bleep numbers • E-mail address to send admission confirmation to

These forms are available on request. Request forms will be e-mailed to the PI and anyone designated by them to request admission of volunteers to the ICRF. All appropriate parts of the admission request form must be completed. Failure to provide appropriate information may mean that the admission cannot be processed or information/interventions on the patient may not happen as required by the protocol.


Once the form is completed it must be forwarded to the ICRF along with any signed drug charts, request forms and any other relevant paperwork for the admission. Upon receipt of the request form and in consultation with the other team leaders, the lead nurse or the nurse in charge will review the request to confirm that an appropriate bed space and the appropriate skill mix of staff is available to facilitate the admission. If the volunteer is not registered with the Trust the Administrator will arrange registration so the volunteer will have a hospital number and medical notes. Scheduling of volunteers will be documented in the CRF Manager system. Patient discharges will also be pre–planned at this stage, to ensure that, as soon as their study visit is completed and their condition permits, they are ready for discharge and where appropriate transport can be arranged.

Research volunteers requiring transport to the Trust will require this to be booked either by the research team or, if agreed at study set up, via the study’s taxi account. Unless otherwise stated any travel expenses will be charged to the study’s expenditure code

Where agreed at study set-up, the CRF administrator will send the volunteer –by post –a letter confirming:

• The address, date, time, duration of visit and purpose of admission. • Discharge date. • A contact point: generally the Principal Investigator or someone delegated by them. • Any special instructions, they require for their admission(s), e.g. If they need to be nil by mouth prior to admission.

The research team should inform the CRF staff if they would like them to do the following:

• Confirm the date of admission. • Identify any special requirements for, or during their admission • Confirm their discharge date. • Confirm how they will travel to the hospital, so that if necessary transport can be booked appropriately. It may be necessary, to avoid late arrival for an investigation, to admit the volunteer a day earlier if they require hospital transport to get to the hospital. Volunteers intending to come to the Hospital by their own car will be encouraged to allow plenty of time before their admission time, because of the problems associated with parking at this site. • They will also be advised if they need to bring an escort with them to ensure that they can be discharged in a safe and timely fashion.

3.0 Related Documents and References: Protocol Review Board Terms of Reference

4.0 Appendices • Appendix 1 Study Contact Roles and Responsibilities • Appendix 2 ICRF application form • Appendix 3 ICRF admission request form single visit • Appendix 4 ICRF admission request multiple visits


Appendix 1: Study Contact Roles and Responsibilities Definition: the Study Contact is a core member of the ICRF staff allocated to oversee the set up and conduct of all studies run in the ICRF, ensuring that the studies are run in compliance with GCP, the study protocol and Trust and departmental SOPs. This includes self-contained studies that do not require substantial nursing or governance input from the CRF and are therefore not routinely allocated to a member of the ICRF A Study Contact will be assigned to all studies: CTIMPs requiring CPM input will be allocated to a Clinical Project Manager (CPM). CTIMPs that do not require CPM input will be allocated to a band 7 nurse or Clinical Trial Assistant (CTA). Non-CTIMPs will be allocated to a member of the nursing team.

Actions: to be completed by the Study Contact • The Study Contact should familiarise themselves with the study protocol • Identify the level of support requested (detailed in the post-PRB version of the study application form) and

ensure that ICRF staff are aware of their required input to the study • Review the study specific risk assessments in the protocol, the post-PRB application form and Phase I risk

assessment form where applicable and make sure relevant staff members are aware of them and that measures are in place to reduce risk.

• Live phase:Update ICRF management on amendments impacting the ICRF, recruitment progress, SAEs, protocol violations, last patient last visit and other notable issues via the Management Meeting spreadsheet

Advice: The Study Contact should inform the research team that they must perform the following

• ICRF induction of the study team (team to contact the CRF administrator) • Ensure clinical competencies and training are in place and up to date (eg GCP, information governance, Pi

access, ANTT and safeguarding children and vulnerable adults.) • PI must ensure that the team read and sign the relevant departmental SOPs. A list of SOPs will be provided. • Study specific SOPs must be approved by the QA Manager • Contact the Data Manager to check that all relevant information is uploaded to CRF Manager so that

bookings can be arranged in a timely manner • Live Phase: Once the study has started the team must inform the Study Contact of any amendments to the

study as early as possible • Live Phase: Team must provide the Study Contact with monthly recruitment figures, SAEs, protocol

violations and any other notable issues relating to study conduct • Live Phase: Meet with the Data Manager or CRF administrator monthly to identify subjects recruited to the

study on CRF Manager. This allows us to run reports on recruitment for our funders • Live Phase: Inform the Study Contact when the last patient last visit for the whole study has occurred • Live Phase: Update the delegation log if new staff/researchers/students become involved with the study

Checks


• Ensure that there is a delegation log and that it is signed by the delegated staff and approved by the PI before the study starts

• Check that source worksheets have been quality controlled by the study team to ensure consistency with the protocol.

• With reference to the study start checklist, check that all the required documents and approvals for the study are in place and filed in the study’s electronic Study Folder and EQMS (where indicated). Copies must also be filed in the paper TMF/ISF but this may be held outside the ICRF by the study team.

• Live Phase: check that all documents and approvals are in place for any amendments


Appendix 2 Application to use the NIHR/Wellcome Trust Imperial CRF This form should be used to make a request to the Imperial CRF for use of the Facility. Please complete and forward together with the study protocol, PI CV and Phase I risk assessment if applicable to the CRF General Manager: Karen Mosley ([email protected]). Section 1 should be completed for the initial submission to the Protocol Review Board (PRB). Section 2 should be completed and all documents submitted before the study starts. * The PRB meets twice monthly, usually on the second and last Thursday of the month. Phase I studies will only be reviewed at the second meeting per month. Applications should be submitted at least 1 week prior to the meeting Section 1

Applicant Details

Principal investigator

Job title

E-mail address Mobile Tel No

Extension Bleep No

Employer details (ICL or ICHNT) If ICL, honorary Trust contract or equivalent held?

Last GCP training date (copies of certificates will be required)

Can the PI be contacted out of hours and/or in an emergency? Yes No Details

Key Staff Details Please enter details of all staff playing key roles in the study and/or requiring access to the CRF Name

Job title

Role in study

E-mail address

Mobile no.

Extension

Employer details (ICL or ICHNT)

Honorary Trust contract held?

Last GCP training date

ICRF access required?

Available to provide medical cover out of hours?*



*PI/delegate Medical Cover: The details of two medically qualified staff are required, ideally the PI and an investigator involved in the study, who will be the medical contacts for the study. They must be included in the delegation logs for the relevant study. See Imperial CRF Medical Cover SOP for further information. NB. At least one person must be contactable after hours Emergency number to be given to participants (actual phone number must be provided)

Project Details

Protocol Title

Study Acronym (to be used as internal study reference )

Outline of overall study design

Speciality Disease area

Study Intervention (if applicable)

If the intervention is classed as an IMP, select IMP status

Unlicensed (anywhere), UK Unlicensed (not licensed in the UK, but is licensed

elsewhere) Unlicensed Use (UK Licence, but used in new indication) Licensed Use

Basis for dose selection (if applicable)

Project type please select all that apply

Experimental Medicine Non-drug intervention Biomarker Diagnostic

Device Epidemiological Observational Screening

NA Other: please state

Clinical Trial of an IMP Phase I FIH Phase I Phase II Phase III

Special requirements

Regulatory information

Ethics Ref No Approval date

R&D Ref No Approval date

EudraCT No (if applicable) MHRA approval date (if applicable)

Have you applied for inclusion on the NIHR portfolio? NIHR portfolio number

For clinical trials: which public database has the study been registered on?


Sponsor and Funding details

Sponsor

Sponsor reference code

Funding Organisation

Value of Award

Management of the study (e.g. research team, CRO, ICRF): provide details

Trust CPG or Division: College staff state which CPG/Division your department tracks to

Funding category Please select

Research Charity Research Council

Own account DH/NIHR (includes BRC)

UK University (HEFCE etc) Other non-commercial eg EU funding

Commercial- PI led Commercial- contract

Non-commercial industry supported (eg drugs or equipment only) State support provided:

Participant Information

Expected start date (at ICRF) Expected End Date (at ICRF)

Total study recruitment target Predicted end date for recruitment at this site (last patient first visit)

Target recruitment for CRF component Of which: Patients

Healthy Volunteers

No. visits/subject (including screening) No. subjects/session

No. overnight stays/subject Is there direct competition with other studies for the same participant group?

How will participants be recruited?


Facilities Required

Facilities required Frequency required (per week)

Average length of use per visit (hours)

Inpatient bed

Side room

Gene Therapy Suite

Side room: negative pressure

Patient monitoring room

Day case bed

Consulting room

Sample handling lab

Intensity of lab use: Low <1 hour per day

Medium>1 <4 High >4

Other please specify e.g. freezer storage, drug storage including storage temperature required, particular rooms

Preferred Days / Times space is allocated on a first come first serve basis. Shaded areas require prior agreement

Sessions 08.00 - 13.00 13.00 - 16.00 16.00-20.00 Overnight stay

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday Equipment required Baxter Volumetric infusion pump Yes No Training required? Yes No Alaris Syringe driver Yes No Training required? Yes No Philips MP50/VM4 cardiac monitor Yes No Training required? Yes No Tympanic thermometer Genius 2 Yes No Training required? Yes No ECG machine GE Healthcare MAC 1200ST Yes No Training required? Yes No Class II Microbiological Safety Cabinet Yes No Training required? Yes No Centrifuge Yes No Training required? Yes No Body Composition Analyser Yes No Training required? Yes No Study specific equipment supplied by study team Yes No Details


Study specific chemicals Will laboratory chemicals be used for this study? Yes No Details If so please confirm that a COSHH form will be completed by the study team and stored in the lab

Yes No

Pharmacy

Where applicable, pharmacy should be contacted before application to the CRF. Contact Victoria Latham, Lead Pharmacist Clinical Trials &Pharmacovigilance Tel: 020 3313 4350 Email: [email protected] Failure to do so will cause delays in study setup Has the Pharmacy Clinical Trials team been contacted? Yes No NA

Any outstanding pharmacy issues (please give details) Yes No Details

Drug administration Please specify

Name of drug Frequency By ICRF staff By research staff

Will any drugs require compounding in the Pharmacy Aseptic Unit? Yes No Maybe

Operational Support required

Will the study require the use of Imperial CRF Operational Staff (e.g. Clinical Project Managers, Data Manager & HV Database administrator: NB resources are limited so we may not be able to offer support)? Yes No If yes, select from the following: Regulatory

Ethics application MHRA application

ARSAC application PRB application support

R&D+/-SSI application TMF/ISF set up and maintenance

Case Report Form

ICRF source data worksheets INFORM development support

Study set-up

Study-specific SOPs

Live study management

Recruitment activities* Day to day coordination of study*

* Items marked with an asterix may also be performed by nursing staff. This can be requested in the section below.



Nursing Input required

Will the study require the use of ICRF nurses? Yes No

If yes, please give details ICRF Medical Cover required

Will the study require the use of ICRF medical cover between normal working hours? Yes No

If yes, please give details

Data collection If an electronic CRF is being used in this study please contact the Trust Information Governance team to ensure that the system complies with security requirements. Email: [email protected] Ensure that you contact the team early in the approvals process to avoid delays. To speed up the process, further information can be found here: http://source/information_governance/information-asset-owners/index.htm

What type of data collection is required? Please select Hard Copy CRF eCRF

Who is responsible for completing the CRF?

Where will the TMF/Site File be stored?

Will there be external monitoring of this study? Yes No

If yes, please provide details:

Study Specific SOPs If your study includes any study specific SOPs these must be sent to the CRF QA Manager via the study contact for review prior to study start.

Will study specific SOPs be utilised for this study? Yes No

If yes, please provide details:


http://source/information_governance/information-asset-owners/index.htm


Risk Assessment All studies applying to the ICRF must be risk assessed to ensure the safety of research subjects. Please complete relevant sections A to D

Study intervention in patients (if applicable)

How complex is the study intervention compared with standard clinical practice?

Simpler as complex

slightly more complex much more complex

NA Is the intervention currently in use in ICHNT to treat patients? Yes No

Do all relevant staff have experience of using the intervention? If no, what training will be provided?

Yes No

Provide details of all other risks associated with the intervention (e.g. route of administration, dose, procedure etc)

Study intervention in healthy volunteers (if applicable)

Is the intervention currently used for research purposes at ICHNT? Yes No

Do all relevant staff have experience of using the intervention? If no, what training will be provided?

Yes No

Provide details of all other risks associated with the intervention (e.g. route of administration, dose etc)

Estimation of risk to research subjects from the research study

Hazard Score Insignificant - no obvious harm Minor - non-permanent harm Moderate – semi-permanent harm Major – major permanent harm or death Extreme – multiple deaths

Likelihood score Rare Unlikely Possible Likely Almost certain

Risk rating of study to research subjects Hazard Score x Likelihood score

Other risks associated with running the study

Patient group that is difficult to recruit to/rare disease? Yes No Details

Scheduling of overnight stays? Yes No Details

Other? Yes No Details


Risk Management Plan (ICRF use only) PRB assessment of overall risk of the research study including risk to investigators and organisation

Low Medium High Extreme Comments

Intervention management

Details

Research Procedure management

Details

Staffing

Details

Training of research staff

Details

PI responsibility for dosing visits level 1, 2 or 3, where

1=PI/delegate present in the CRF: 2= PI/delegate able to attend CRF within 5 minutes: 3= PI/delegate available by phone

Details

Risk Matrix

Likelihood

Consequences

Insignificant

1

Minor

2

Moderate

3

Major

4

Extreme

5

5 (almost certain) 5 (M) 10 (H) 15 (E) 20 (E) 25 (E)

4 (likely) 4 (M) 8 (H) 12 (H) 16 (E) 20 (E)

3 (possible) 3 (L) 6 (M) 9 (H) 12 (E) 15 (E)

2 (unlikely) 2 (L) 4 (L) 6 (M) 8 (H) 10 (E)

1 (rare) 1 (L) 2 (L) 3 (M) 4 (H) 5 (H)


Section 2: Documents to be forwarded before the study starts

Document Attached, in progress or NA

Further information eg expected approval date

Study Protocol including date & version

Sponsor letter

Imperial CRF risk assessment form for Phase-I studies

Proof of funding

Patient Information sheet, consent form and GP letter including date & version

Consent form including date & version

GP letter including date & version

Other patient materials e.g. contact card, diary

REC application (parts A&B )

Ethics SSI form (part C)

Approval (favourable opinion) letter from REC

R&D approval letter

GCP certificates for the whole research team

Signed, dated CVs for the whole research team

ALS/ILS/BLS certificates for PI and/or main researchers

MHRA approval letter (if applicable)

Evidence (email/letter) of approval by Joint Clinical Research Safety Committee (old GT GMSC) as applicable

Other approvals if applicable eg ARSAC

Investigator’s Brochure (where applicable)

Laboratory manual (if applicable)

(For clinical trials) Confirmation that the study has been registered on a publicly accessible database e.g. www.clinicaltrials.gov

Confirmation that the study has been registered for inclusion in the NIHR portfolio (if applicable)

• Lead Investigator Obligations to Imperial College Healthcare NHS Trust and Imperial CRF

I agree that as Principal Investigator I will have overall responsibility for the conduct of this research study at this site

I confirm that this study will be conducted in accordance with ICH-GCP and in compliance with the protocol


I confirm that I will read all Imperial CRF SOPs relevant to this study and agree to comply with them and any future updates

I agree to ensure that all associates, colleagues and employees assisting in the conduct of the study are informed about their obligations and will read the applicable Imperial CRF SOPs.

I agree that the research team nurses when working on the Imperial CRF are accountable to the CRF’s Lead Nurse

I confirm all study staff involved in the study have Trust, Honorary or Honorary Research contracts with Imperial College Healthcare NHS Trust

I confirm that responsibility for indemnity against negligent harm is held

I agree as Principal Investigator that all research related costs will be met where applicable

PI’s Name Date

• Permission to use Imperial CRF facilities is granted for one year and reviewed annually thereafter. A renewal letter will be sent 2 months prior to the annual review date; failure to reply will mean the study is no longer

eligible to use the facilities. Please email this form and supporting documents to Karen Mosley ([email protected]) PRB Study Approval (ICRF completion only)

Name Date

Signature

PRB comments

Named ICRF contact for this study (ICRF completion only)

Name Date

Signature

Study ID (ICRF completion only)

Study Acronym

ICRF Study Number

Overall Study Risk

Study Intensity

Confirmation that PI accepts the post-PRB changes (to be completed by the PI once the post-PRB changes have been received)

Name Date

Signature



Appendix 3

Admission Request Form NIHR/Wellcome Trust Imperial CRF

Participant’s Name, address AND date of birth

Male Female

Hospital number NHS number

Volunteer’s Tel No. Home: Mobile: Work:

Any Imaging required? Please specify what, where and when

YES NO

Transport: Own Transport: Research team to arrange: Imperial CRF to arrange:

Interpreter YES NO Any mobility issues Please specify

YES NO

Imperial CRF Medical cover YES NO Imperial CRF Nursing cover YES NO

Patient or Healthy Volunteer Study acronym

Ethics No. JRO/R&D code

Consultant

Bed male bay Admit Date Admit Time

Bed female bay Discharge Date Discharge Time

Gene therapy suite Visit Name (eg screening)

Negative pressure side room Additional page attached for follow on visits

Standard side room Date

Patient monitoring room 1,2 or 4 Sign

Patient monitoring room 3 Please Print your name

Consulting room 1, 2 or 4 (small) E-Mail address:

Consulting room 3 (large) Mobile number:

Please return to reception by either Trust e-mail to [email protected], by fax or by hand. NB no requests accepted less than 24 hours prior to appointment unless discussed with senior staff first.



Appendix 4 Admission Request Form NIHR/Wellcome Trust Imperial CRF

Participant’s Name, address AND date of birth

Male Female

Hospital number NHS number

Volunteer’s Tel No. Home: Mobile: Work:

Any Imaging required? Please specify what, where and when

YES NO

Transport: Own Transport: Research team to arrange: Imperial CRF to arrange:

Interpreter YES NO Any mobility issues Please specify

YES NO

Imperial CRF Medical cover YES NO Imperial CRF Nursing cover YES NO

Patient or Healthy Volunteer Study acronym

Ethics No. JRO/R&D code

Consultant

Bed male bay Admit Date Admit Time

Bed female bay Discharge Date Discharge Time

Gene therapy suite Visit Name (e.g. screening)

Negative pressure side room Additional page attached for follow on visits

Standard side room Date

Patient monitoring room 1,2 or 4 Sign

Patient monitoring room 3 Please Print your name

Consulting room 1, 2 or 4 (small) E-Mail address:

Consulting room 3 (large) Mobile number:

Please return to reception by either Trust e-mail to [email protected], by fax or by hand. NB no requests accepted less than 24 hours prior to appointment unless discussed with senior staff first.



Ethics Number

JRO/R&D code NHS Number Hospital Number

Follow-up 1

Admit Date Admit Time

Discharge Date Discharge Time

Name of visit (eg screening) Any comments

Imperial CRF Nursing cover: YES NO Imperial CRF Medical cover: YES NO

Follow-up 2





Follow-up 3





ICRF-POL001.05 Application to use the ICRF 24th July 2013

of 22

Follow-up 4





Follow-up 5





APPLICATION TO USE THE NIHR/WELLCOME TRUST...

Documents

Transcript of APPLICATION TO USE THE NIHR/WELLCOME TRUST...