Pharmacy Clinical Trials Questionnaire RHH

Pharmacy Clinical Trials Questionnaire RHH

Directorate of Pharmacy and Medicines Management

Pharmacy Clinical Trials Questionnaire RHH

Please return the completed questionnaire to Helen Bowler either by e-mail or post.

E-mail:

Post: Helen Bowler, Pharmacy Clinical Trials manager, Pharmacy Department, RoyalHallamshireHospital, Glossop Road, Sheffield, S10 2JF

Please also send to the address above:

  • A paper copy of the protocol (if not already sent)
  • A copy of labelling of study medication
  • Electronic copies of all forms

Study Title:
Protocol No:
Sponsor:
CRO (if applicable)
CRA contact details
Name
Tel no
Mobile
Fax no
e-mail address
postal address
  1. Name of Principal Investigator

  1. If the study is registered with the Research Department please provide the STH number

  1. NIHR portfolio study
/ Yes
No
  1. How is the study funded
/ Please selectCommercial companyCommercial grantGrantNIHR support fundingInvestigator accountSTH Directorate
  1. Please indicate who pharmacy costs should be sent to
(N.B. Agreed pharmacy costs are to be included in the main Clinical Trial Agreement)
  1. Intended start date

  1. Intended completion date

  1. Duration of recruitment

  1. Expected number of patients at this site

  1. Duration of treatment per individual patient

  1. Number of dispensing episodes per patient

  1. Randomisation
/ Please selectIVRS/IWRSSequential allocation (investigator)Sequential allocation (pharmacy)other (please specify)no randomisation required
  1. Are any aseptic services required
(If yes please complete questions 14 to 22 below. If no please go to question 23) / Yes
No
  1. Please specify any special handling requirements

  1. Please specify any special cleaning/decontamination requirements

  1. What is the stability data for the product once prepared

  1. What are the storage requirements of the prepared product (shelf life and temperature)

  1. Are diluents provided
/ Yes (If yes please provide details)
No
  1. Are disposables provided
/ Yes (If yes please provide details)
No
  1. Is a specific needle gauge required
/ Yes (If yes please provide details)
No
  1. Are specific filters required
/ Yes (If yes please provide details)
No
  1. Are specific syringes or infusion bags required
/ Yes (If yes please provide details)
No
  1. Is the investigational medicinal product a controlled drug
/ Yes
No
  1. Is the investigational medicinal product a cytotoxic agent
/ Yes
No
  1. Is the investigational medicinal product a gene therapy agent
/ Yes
No
  1. Please indicate whether returned study medication will be uplifted and indicate frequency of uplift of returned medication. N.B. We are only able to destroy on site in certain circumstances and with prior agreement
/ Please selectconfirmednot confirmedon-site destruction (to be agreed)
Please selectAt each monitoring visitAs returns build up on an ongoing basisAt the end of the study
Drug accountability (Receipt)Please indicate all that apply if more than one (e.g. fax back and IVRS)
  1. Paper receipt to be faxed back
/ Yes
No
  1. Paper receipt to be posted back
/ Yes
No
  1. IVRS
/ Yes
No
  1. IWRS
/ Yes
No
Drug accountability (Dispensing)
  1. Is a prescription form provided
/ Yes
No
  1. Are dispensing records provided
/ Yes
No
  1. Are overall drug accountability forms provided
/ Yes
No
  1. Patient returns, mark all that apply:
Not required
Count & record
Record only
Save for CRA
Return to sponsor / Yes No
Yes No
Yes No
Yes No
Yes No
Code break (Double-blind studies) Where the investigator has access to break the code via an IVR or IWR system a back up is required to be held by the pharmacy department. This can be a 24 hour access telephone number provided by the sponsor to someone who can break the code if required.
  1. Please provide code break details

Monitoring
  1. Who will monitor the study
/ Sponsor
CRO
  1. What is the expected frequency of monitoring visits

Please complete for all drugs included in the protocol (not just IMP)
#1Drug name / Formulation / Strength(s)/Concentration
Please selectTabletCapsuleOral solutionVialAmpouleOther ......
Source of supply / Storage / How packaged
Please selectProvided by sponsor FOCProvided by sponsor at a discountProvided by site and reimbursedProvided by site / Please selectRoom temperature (up to 25oC)Room temperature (up to 30oC)Refrigerator (2-8oC)Freezer (-20oC)Freezer (-40oC)Freezer (-80oC)
Please provide details of reimbursement of any medication to be provided by site
Initial supplies / Subsequent supplies / Time from order to receipt
Please selectSent by sponsor when site activatedSent by sponsor when 1st patient screenedSite to orderN/A - using sites own supplies / Please selectAutomaticPharmacy to order - fax formPharmacy to order - e-mail formPharmacy to order - IVRS/IWRSPharmacy to order - other .....
Please provide an estimated pack size and quantity to be stored
Are any temperature excursions permitted (If yes please provide details of any permitted temperature excursions / Yes No
What is the notification process for temperature excursions

N.B. If more than one drug please also complete the extra drug detail forms on pages 5 and 6 as necessary

Completed By:
Date:
#1Drug name / Formulation / Strength(s)/Concentration
Please selectTabletCapsuleOral solutionVialAmpouleOther ......
Source of supply / Storage / How packaged
Please selectProvided by sponsor FOCProvided by sponsor at a discountProvided by site and reimbursedProvided by site / Please selectRoom temperature (up to 25oC)Room temperature (up to 30oC)Refrigerator (2-8oC)Freezer (-20oC)Freezer (-40oC)Freezer (-80oC)
Please provide details of reimbursement of any medication to be provided by site
Initial supplies / Subsequent supplies / Time from order to receipt
Please selectSent by sponsor when site activatedSent by sponsor when 1st patient screenedSite to orderN/A - using sites own supplies / Please selectAutomaticPharmacy to order - fax formPharmacy to order - e-mail formPharmacy to order - IVRS/IWRSPharmacy to order - other .....
Please provide an estimated pack size and quantity to be stored
Are any temperature excursions permitted (If yes please provide details of any permitted temperature excursions / Yes No
What is the notification process for temperature excursions
#1Drug name / Formulation / Strength(s)/Concentration
Please selectTabletCapsuleOral solutionVialAmpouleOther ......
Source of supply / Storage / How packaged
Please selectProvided by sponsor FOCProvided by sponsor at a discountProvided by site and reimbursedProvided by site / Please selectRoom temperature (up to 25oC)Room temperature (up to 30oC)Refrigerator (2-8oC)Freezer (-20oC)Freezer (-40oC)Freezer (-80oC)
Please provide details of reimbursement of any medication to be provided by site
Initial supplies / Subsequent supplies / Time from order to receipt
Please selectSent by sponsor when site activatedSent by sponsor when 1st patient screenedSite to orderN/A - using sites own supplies / Please selectAutomaticPharmacy to order - fax formPharmacy to order - e-mail formPharmacy to order - IVRS/IWRSPharmacy to order - other .....
Please provide an estimated pack size and quantity to be stored
Are any temperature excursions permitted (If yes please provide details of any permitted temperature excursions / Yes No
What is the notification process for temperature excursions
#1Drug name / Formulation / Strength(s)/Concentration
Please selectTabletCapsuleOral solutionVialAmpouleOther ......
Source of supply / Storage / How packaged
Please selectProvided by sponsor FOCProvided by sponsor at a discountProvided by site and reimbursedProvided by site / Please selectRoom temperature (up to 25oC)Room temperature (up to 30oC)Refrigerator (2-8oC)Freezer (-20oC)Freezer (-40oC)Freezer (-80oC)
Please provide details of reimbursement of any medication to be provided by site
Initial supplies / Subsequent supplies / Time from order to receipt
Please selectSent by sponsor when site activatedSent by sponsor when 1st patient screenedSite to orderN/A - using sites own supplies / Please selectAutomaticPharmacy to order - fax formPharmacy to order - e-mail formPharmacy to order - IVRS/IWRSPharmacy to order - other .....
Please provide an estimated pack size and quantity to be stored
Are any temperature excursions permitted (If yes please provide details of any permitted temperature excursions / Yes No
What is the notification process for temperature excursions
#1Drug name / Formulation / Strength(s)/Concentration
Please selectTabletCapsuleOral solutionVialAmpouleOther ......
Source of supply / Storage / How packaged
Please selectProvided by sponsor FOCProvided by sponsor at a discountProvided by site and reimbursedProvided by site / Please selectRoom temperature (up to 25oC)Room temperature (up to 30oC)Refrigerator (2-8oC)Freezer (-20oC)Freezer (-40oC)Freezer (-80oC)
Please provide details of reimbursement of any medication to be provided by site
Initial supplies / Subsequent supplies / Time from order to receipt
Please selectSent by sponsor when site activatedSent by sponsor when 1st patient screenedSite to orderN/A - using sites own supplies / Please selectAutomaticPharmacy to order - fax formPharmacy to order - e-mail formPharmacy to order - IVRS/IWRSPharmacy to order - other .....
Please provide an estimated pack size and quantity to be stored
Are any temperature excursions permitted (If yes please provide details of any permitted temperature excursions / Yes No
What is the notification process for temperature excursions

Pharmacy questionnaire for clinical trials RHH version 4 March 2010

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