Boc Clinical Trials Executive Committee

BOC CLINICAL TRIALS EXECUTIVE COMMITTEE - PROTOCOL SUBMISSION FORM

E-MAIL 2 WEEKS PRIOR TO MEETING: ;

In order to aid the CTEC discussion of this protocol, this form MUST be completed as fully as possible by the PI.

This will ensure any logistical/practical concerns have been identified and addressed prior to approval.

Principal Investigator / Protocol title / Date of CTEC: / Month: / Year:

Sponsor/CRO details

Sponsor/CRO / COMMERCIAL / NON-COMMERCIAL
Contact name & title
E:mail address
Telephone no

Section 1: ProtocolReview & CTU support

Is this protocol approved by ITAB
In-house Trials Advisory Board ( IHTAB) acts as a peer review for new research that will require CRUK CTU input or support in its capacity as a CRUK/UKCRC registered CTU / YES / NO
Is this protocol Ethics/MHRA approved?
If no detail status of trial protocol
Has the study been adopted by NCRN? / YES / NO / UNSURE / PENDING
Are there any competing studies that would accrue same patient population?
If yes, detail why this protocol being considered?
Document protocol discussion and agreement with relevant site specific team.
If non-commercial detail any funding in place for study.
Detail NHS funding required for any non-SOC drugs or other interventions?
Detail any activities specified within protocol and unique to the trial, but within normal remit of the clinical responsibility for that member of staff
(e.g. the administration of IV Investigational Medical Product (IMP) by a nurse trained in the administration of IV drug?
For CTEC Administration only:
Risk Assessment: Yes / No
Any other issues to highlight?
Recruitment figures per month as agreed in contract?
Please be realistic as this will be used as criteria for reviewing performance of study
Does study require CTU Regulatory Administration to support local SSI completion and R&D submission?
Does the study require CTU data management?
Does the study require retrieval of archival tissue blocks? / YES / NO

Section 2: Beatson SiteReview(do not complete if study only running at network sites)

Section 2A - Radiotherapy Review

Is RMG approval required? / YES
Detail below / NO
Indicate reason:
Go to section 2B
Document extra resource required and status of approval.

Section 2B - Pharmacy Review

Will pharmacy be dispensing any drugs as part of the study? / YES / NO
If yes submit protocol to clinical trials pharmacist for comments at the earliest opportunity
Document input and discussions with trial pharmacist if these drugs IMPs?

Section 2C - SACT Review

Detail drug regime highlighting which parts are additional to standard of care
(including frequency & duration of infusions)
Detail where patients will be reviewed and treated within Beatson.
Estimate number of treatment visits compared to standard treatment per patient in each arm of study.
If treatment continues to PD, give average length.
Detail any saving to GGC
(eg drug cost/resource saving etc)
Is CMG approval required? / YES
Detail below
For CMG review / NO
Indicate reason:
Go to section 2D
Detail any extra resource required
(eg extra chair time for monitoring, gap between drugs)
Detail any specific nursing input above standard
(eg repeat obs, urinalysis, specific giving sets)
Detail if specific day required for treatment in MDBU
Detail any nursing staff training required
(eg unfamiliar drug)
Estimate start date for study

Section 2D – Research Nurse and sample handling review

Document any research nurse input and discussions with CRU/Beatson SCRN manager.
Detail any research/central samples and provide details of processing.
If samples/ECG are pre-dose, confirm sponsor in agreement they can be taken within 24 hours, along with pre-chemo clinic assessments.
Does the study require input from ASU? / YES / NO If yes provide details below
Detail any ASU/ECMC input and status of ASU request form.
Does the study require fresh biopsy? / YES / NO If yes provide details below
Detail when, where and how biopsy will be taken and handled, highlighting any biobank involvement.
If CRU study, indicate secretarial support
Discuss with CRU SCN if clarification required / CRU admin assistant / Consultant secretary

Section 3: Radiology Review

Which imaging services will be used? / NHS / CRF / Ross Hall
If Ross Hall remainder of section does not need completed
Document scanning required over what timescale and indicate what is or not additional to standard of care
What reporting criteria requirements does the trial have?
Has a radiologist been approached for NHS/CRF / YES / NO If yes provide details

Section 4: Scottish Cancer Research Network Review

Will the trial be run at any sites outwith BWoSCC? / YES / NO If yes provide details
Document any SCRN support required and discussions with SCRN manager.

Thank you for your assistance. Please remember that protocols must be submitted to the CTEC before SSI/R&D submission.

Allow at least 2 weeks after CTEC approval for any paperwork to be completed by Trials Office staff for SSI/R&D submission.

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