Application to Use the NIHR/Wellcome Trust Imperial CRF

Application to use the NIHR/Wellcome Trust Imperial CRF

Please complete and forward this form together with the following documents to the ICRF General Manager: Karen Mosley ([email protected]) one week prior to the PRB meeting: All studies: study protocol and PI CV CTIMP/CT-device studies: Clinical Risk Assessment and Management form (CRAMP) Phase I studies: Investigators Brochure and Phase I additional information form

Study ID (ICRF completion only) Study Acronym ICRF Study Number Overall Study Risk Study Intensity

Applicant details Principal investigator Job title

E-mail address Mobile No. Extension Employer details (ICL If ICL, end date of honorary or ICHNT) Trust contract (or LtA) held? Can the PI be contacted out of Yes No Last GCP training date hours and/or in an emergency? Details ICRF access required? Yes No ICRF induction required? Yes No

Study team details Include details of all team members who will either use the ICRF or coordinate the study. If more than four, please send details in the cover email. Name

Job title

Role in study

E-mail address

Mobile no.

Extension

Employer details (ICL or ICHNT) If ICL, end date of honorary Trust contract (or LtA) held? Last GCP training date

ICRF access required? Yes No Yes No Yes No Yes No

ICRF induction required? Yes No Yes No Yes No Yes No

ICRF-OR09 Form 1 v7 ICRF Application form: September 2016 Page 1 of 14 Medical cover out of hours?* Yes No Yes No Yes No Yes No

*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. NB. At least two people must be contactable after hours

Emergency number to be given to participants (actual phone number must be provided)

Study details Protocol Title

Study Acronym (to be used as internal study reference)

Outline of overall study design Speciality Disease area

Study Intervention name (if applicable) Unlicensed (anywhere), UK Unlicensed (not licensed in the UK, but is licensed If the intervention is classed as an IMP, select IMP elsewhere) status Unlicensed Use (UK Licence, but used in new indication) Licensed Use Project type: select all that apply

Clinical Trial of Phase I FIH Phase I Phase II Phase III Phase IV an IMP Experimental Medicine Randomised study Observational

1y intervention 2y intervention 3y intervention

Other intervention: please state

Patients or HV? TOPS required? Yes No If the study is multicentre and includes other NIHR CRFs, please list Summary of required input from the ICRF, and ID of all visits (including phone visits) to be performed in the ICRF &/or by ICRF staff

Regulatory information Ethics Ref No JRCO/R&D Ref No UKCRN No. if EudraCT No. if applicable applicable IRAS code

ICRF-OR09 Form 1 v7 ICRF Application form: September 2016 Page 2 of 14 Sponsor and Funding details Sponsor reference Sponsor code Funder Total funding awarded

Funding category If commercial If NIHR Management of the study (e.g. research team, CRO, Trust Division ICRF. If CRO give name)

CRF visit requirements

Total study Target recruitment Of which: Patients recruitment target for CRF component Healthy Volunteers No. visits/subject at the ICRF (including No. overnight screening and phone stays/subject visits) Expected start date Expected End Date (at ICRF) (at ICRF)

Rooms required Frequency Average length Frequency Average length of Room required required/week of use (hrs/visit) Room required required/week use (hrs/visit)

Intensity of lab use per day: Low <1 hour Medium>1 <4 High >4

Other please specify Sessions required Core hours are 8-5 Monday to Friday. Indicate below if you require evening, overnight and/or weekend visits Evening (after 5pm) Overnight Mon to Thu Overnight Fri to Sun Weekend day

Details

Equipment required Select if equipment required Select if training required Calorimeter Exercise Bike Sleep equipment Baxter Volumetric infusion pump Alaris Syringe driver Philips MP50/VM4 cardiac monitor ICRF-OR09 Form 1 v7 ICRF Application form: September 2016 Page 3 of 14 Tympanic or oral thermometer ECG machine GE Healthcare MAC 1200ST Class II Microbiological Safety Cabinet Centrifuge Body Composition Analyser Diet Kitchen Freezers (researchers will be added to the tscan alarm alerts) Study specific equipment supplied by study team Details

Study specific chemicals Will laboratory chemicals be used for this study? Yes No Details

ICRF staff required Indicate below if ICRF staff will be required other than in an emergency. If you answer yes to any question you must complete appendix 1. This is a request for ICRF staff only and in some cases we will not be able to support the request. NB Medical and laboratory staff are available only 9 – 5 and due to limited number of staff their availability for any given visit cannot be guaranteed.

Nursing staff: Medical staff: Operational staff: Laboratory staff: Yes No Yes No Yes No Yes No

Drug related details Pharmacy must be contacted if your study involves a drug. Contact [email protected] Does your study involve an IMP and/or other drug? Yes No Has the Pharmacy Clinical Trials team been contacted? Yes No Not yet N.B. If there are any drugs involved in your protocol even if not a CTIMP, Pharmacy must be contacted Has the Pharmacy Trial Notification form (MF14) and final protocol been provided? Yes No NA Frequency of Drug supply (NHS supply admin Name of drug or other-give By ICRF staff By research staff istrati details) on

Will any drugs require blinding or Aseptic compounding in Pharmacy? Yes No Maybe Please specify why if ‘Yes’ or ‘Maybe’ Will the drug(s) be stored in the ICRF? Yes No Does the drug require reconstitution? Yes No If yes, where will this be carried out? Pharmacy ICRF TBC

Data collection/monitoring What type of data Hard Copy CRF Who is responsible for ICRF-OR09 Form 1 v7 ICRF Application form: September 2016 Page 4 of 14 collection is required? eCRF completing the CRF? Will there be external Yes No If yes, please provide monitoring of this study? details:

Study specific procedures NB wherever possible all procedures should be included in the protocol. Any standalone written procedures must be reviewed by the ICRF QA Manager Will written study specific procedures be utilised for this Yes No study? If yes, please provide details:

Imaging details Imaging facility to be used ICCIF Imanova Other ICCIF users only: No. scans per participant Expected duration of scan Visit ID eg visit 2 PET Yes No MRI Yes No

Patient & Public Involvement

Has this study included any PPI Yes No

If yes, please provide details:

If no, would you like input from the ICRF PPI Panel to Yes No review your study +/- documents? Do you wish the study to be added to the ICRF website to support recruitment (must be included in ethics Yes No application)?

Operational Assessment Risk Area Description (Risk Significance Score*) Score Study Design and Management Double Randomised Clinical Trial Cohort / Cross- blind/adaptive 9 Controlled 6 3 1 (Open-Label) Sectional 1. Complexity /multiple arms Trial of study design Experimental Proof of First in human 9 Medicine/ 6 3 concept Phase IIa Non- 2. Trial Commercial commercial 4 2 management study study Study Procedures 3. Interventions New or Non- 9 Invasive 6 Invasive 4 Study limited to 1 (including IMP standard intervention intervention blood samples administration) intervention currently currently and/or not previously undertaken undertaken by questionnaire

ICRF-OR09 Form 1 v7 ICRF Application form: September 2016 Page 5 of 14 within Trust undertaken in that are new ICRF Staff only the Trust to the ICRF Any visit Visits within core 4. Study Visits outside core 9 Outreach/Lone working/home visit 5 1 working hours hours Investigational Medicinal Product 5. IMP ATIMP or No IMP dosing 8 IMP or Device 6 2 No IMP 0 Involvement GMO in ICRF Phase I Phase II or Non- pilot/proof of 9 other interventional Observational or 6. Phase or type concept/FIH Interventional 6 Exp Med or 4 Epidemiological 1 of Clinical Study Experimental Phase III, Phase Studies Medicine IV Participants Adults lacking capacity / Healthy 7. Participant Children / Volunteers with Healthy 8 Patients 6 4 1 Group Complex or chronic Volunteers specialist care conditions needs Investigator PI with no No previous previous No previous Adequate training 8. Investigator clinical clinical 9 6 studies in the 4 and experience to 1 Experience research research ICRF support this study studies in NHS experience Laboratory 9. New or hazardous samples or lab Yes, High risk 9 Yes 6 Maybe 4 No 0 processing methods Resources 10. Intensity Score (to be High 6 Medium 4 Low 2 completed by the ICRF) Any other perceived risk

Add risk 9 6 4 2

Risk Minimisation strategies

Residual Risk

ICRF-OR09 Form 1 v7 ICRF Application form: September 2016 Page 6 of 14 Comments

Protocol Operational risk score Total score version checked by If score is <15 consider Score rating High >44 Medium 30-44 Low 15-30 whether ICRF is needed

ICRF-OR09 Form 1 v7 ICRF Application form: September 2016 Page 7 of 14 Documents to be forwarded before the study starts Attached (A), in Further information ICRF Document progress (P) or NA (eg date & version) checklist All studies Study Protocol Patient Information sheet and consent form REC application REC Approval letter HRA approval letter Confirmation of Capacity and Capability email List of all researchers involved in the study with contact details if not all included in this application GCP certificates for the research team Signed, dated CVs for the research team Signed off delegation log All CTIMP studies MHRA approval letter ICRF Clinical Risk Assessment & Management Plan Investigators Brochure/SmPC Phase I studies ICRF Phase I Additional Information Form Dose escalation plan for FIH studies if applicable Where applicable ICRF Clinical Risk Assessment & Management Plan (CRAMP) for non-CTIMP studies where requested at PRB Lone working: ALS/ILS certificates New Interventions Committee approval for device studies Other approvals eg ARSAC Joint Clinical Research Safety Committee approval and risk assessment for GMO studies Laboratory manual Clinical trial agreement/contract

NB: If the trial master file/investigator site file is to be held in the CRF, all study related documents must be submitted

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 I, or a delegate, will cover all medical visits if required. I agree that the research team nurses when working on the Imperial CRF are accountable to the CRF’s Lead Nurse ICRF-OR09 Form 1 v7 ICRF Application form: September 2016 Page 8 of 14 I confirm all study staff involved in the study have substantive or honorary 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 I agree that I will acknowledge the Imperial CRF in all publications using the following wording: This article/paper/report presents independent research funded by [name of funder] and supported by the NIHR CRF and BRC [as applicable] at Imperial College Healthcare NHS Trust. 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

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

Confirmation that PI accepts the post-PRB changes (to be completed by the PI once the post-PRB changes have been received). NB the study will not start until the signed copy has been received

Name Date Signature

Appendix 1 Clinical, Medical and Operational responsibility NB this will be reviewed at PRB and changes made where required. Additional forms will be completed if changes are agreed once the study has been approved (green indicates CTIMP only) Due to a limited number of medical staff, tasks requiring a clinician cannot be guaranteed for any particular visit, and only between 9 – 5. Version number Date

ICRF Type Responsibilities NA Study team team

Recruitment Recruitment of participants HV Recruitment Letter to GP requesting medical history and/or informing them of participation in clinical trial

ICRF-OR09 Form 1 v7 ICRF Application form: September 2016 Page 9 of 14 (pre-enrolment) Letter to GP requesting medical history and/or Non-HV Recruitment informing them of participation in clinical trial (pre-enrolment) Registration on TOPS (HV Recruitment CTIMP) Visits Screening Visits Consenting Send letters to GPs once Visits subject enrolled (HV) Send letters to GPs once Visits subject enrolled and completed (Patients) ICRF Admission Assessment procedures for Visits overnight stay (eg. VTE, MRSA swabs, checklists) Routine procedures eg Visits Vital Signs, ECGs, cannulation Study specific assessments Visits (neurological scales etc) Booking external assessments (e.g. X-Ray, Visits US, Lung Function, ECHO etc) Uploading results (eg CT, Visits ECHO, ECG etc) and answering queries IMP/drug management Visits (ordering, manage excursions etc.) IMP collection from Visits pharmacy Visits PK sampling Prescriptions (of IMP or Visits otherwise if applicable) Administration of drugs Visits (IMP or otherwise) AE and SAE source worksheet completion Visits (bar causality and seriousness) AE and SAE causality and Visits seriousness source worksheet completion SAE/SUSAR reporting to Visits sponsor

ICRF-OR09 Form 1 v7 ICRF Application form: September 2016 Page 10 of 14 SUSAR reporting to Visits MHRA/REC General medical cover (chronic management/ Visits routine follow up/ECG review etc) Specific clinical procedures Visits (eg. LP, Arterial lines, biopsy) Visits Medical cover within hours Study out of hours medical Visits cover (usually study team) Dose escalation decision Visits (Phase I CTIMP) dissemination Tracking and ordering of study specific supplies e.g. Visits lab kits, ECG consumables etc Registration of study Visits specific equipment Arranging calibration of Visits clinical equipment Laboratory Processing of samples Laboratory Booking shipments Shipping and tracking of Laboratory samples Tumour sample requests Laboratory and tracking Arranging calibration of lab Laboratory equipment Completion/reporting of Laboratory lab deviations Development and Data collection maintenance of Source Worksheets Source Worksheets Data collection completion Data collection Source Worksheets review Data collection eCRF design Data collection eCRF UAT Data collection eCRF amendments Data collection eCRF data entry Data collection eCRF query resolution Data collection eCRF production of reports eCRF data extraction Data collection request Data management MedDra coding

ICRF-OR09 Form 1 v7 ICRF Application form: September 2016 Page 11 of 14 Bookings and expenses Requesting study visits Bookings and expenses Booking accommodation Bookings and expenses Booking taxis Reimbursement of Bookings and expenses participant travel expenses Bookings and expenses Set up study cab account Track study expenditure Bookings and expenses (ICRF) Track study expenditure Bookings and expenses (external departments i.e PET, lung function etc) Record and disseminate Study meetings key information Organise SIV and prepare Study meetings documentation (delegation log, attendance lists etc) Organise any other training Study meetings required and prepare documentation Organise trial management Study meetings meetings Document, disseminate Study meetings and file trial management meetings Organise Data & Safety Study meetings Monitoring Committee meetings Document, disseminate and file Data & Safety Study meetings Monitoring Committee meetings iISF/iTMF set-up and Regulatory/Governance maintenance Trial registration and Regulatory/Governance updates (clinicaltrials.gov) Ethics, R&D & MHRA Regulatory/Governance submissions and approvals Ethics, R&D & MHRA Regulatory/Governance amendments and approvals Liaison with external departments at study start Regulatory/Governance and during the study (i.e imaging, pharmacy, lung function, ECHO etc) Ensure all approvals are in place prior to study start Regulatory/Governance and implementation of any amendments Regulatory/Governance Inform study team and

ICRF-OR09 Form 1 v7 ICRF Application form: September 2016 Page 12 of 14 ICRF once approvals are in place prior to study start and implementation of any amendments Review and update of Regulatory/Governance protocol and trial documentation Maintenance of version Regulatory/Governance history log Contract co-ordination (PK Regulatory/Governance lab, monitors etc) ICRF Amendment Form Regulatory/Governance Completion Liaison with Sponsor, Regulatory/Governance Funder and R&D Maintain Screening and Regulatory/Governance Enrolment and Subject ID logs Upload NIHR accruals (if Regulatory/Governance applicable) Regulatory/Governance Update Documas Update ClinTrials.Gov (if Regulatory/Governance applicable) Regulatory/Governance Update PRB when required Regulatory/Governance Maintain Delegation log Ensure appropriate medical cover and Regulatory/Governance documentation is in place (CRAMP or equivalent) Ensure SAE tracker is maintained and track SAEs Regulatory/Governance to ensure they are followed up to resolution QC of safety data/IDMC Regulatory/Governance data for dose escalation Update study team contact Regulatory/Governance details Update emergency contact Regulatory/Governance details Reporting of urgent safety Regulatory/Governance measures Completion of deviations, Regulatory/Governance violations, breaches Reporting of deviations, Regulatory/Governance violations, breaches Regulatory/Governance Annual reporting (Ethics) Developmental Safety Regulatory/Governance Update Reporting input (DSUR-MHRA) Regulatory/Governance Completion of ICRF annual ICRF-OR09 Form 1 v7 ICRF Application form: September 2016 Page 13 of 14 renewal forms Regulatory/Governance Progress reports to funder Regulatory/Governance Accrual reporting Organise and host Regulatory/Governance monitoring visits Book monitoring visits on Regulatory/Governance CRF manager Regulatory/Governance End of trial notification(s) Provide documentation Regulatory/Governance required to monitor Review of final study Regulatory/Governance report Regulatory/Governance Close out activities Regulatory/Governance Archiving

ICRF-OR09 Form 1 v7 ICRF Application form: September 2016 Page 14 of 14