RASCAL PT-TrakID:  Brief title: 
Submitted by:        Created:    Modified:   

Please complete the entire form so the Research Pharmacy may provide you with a cost estimate.
Return the completed form to researchpharmacy@columbia.edu as an e-mail attachment or fax to 201-568-6148. Include a copy of the protocol if not submitted prior.


IRB# (if available):

Contact Information:

Principal Investigator: UNI: Name:
Department:
Telephone: Pager:
E-mail:

Study Coordinator:
Telephone: Pager:
E-mail:

Business Administrator:
Telephone: Pager:
E-mail:

Study Title:
Protocol #:

Study Description:    (check all that apply)      Inpatient      Outpatient      Multicenter
On Call Study:      Yes    No               Weekend or Holiday dispensing?     Yes    No
Sponsor:                Investigator Initiated      NCI      SWOG      CCG      COG

Pharmaceutical Industry Sponsored:
Spon Name: Spon Prot#
Spon Contact Name: Phone:
Fax: E-mail:

Service requested:     (check all that apply)
Dispense:
Capsules/Tablet Patient Kit IV Product Pre-filled Syringes
Ointment/Cream Other
Manufacture:
Capsules Patient Kit IV Product Ointment/Cream
Other

Drug returns: (Investigator: if unsure, check with study sponsor):
No drug returns to Research Pharmacy, Investigator will oversee drug return and destruction via OSHA, EPA, DEA compliant methods
Used drug supplies will be returned to Research Pharmacy for immediate destruction
Used drug supplies will be returned to Research Pharmacy for storage and reconciliation by study monitor, and then destruction or return to sponsor
Used drug supplies generated in the pharmacy must be stored in the Research Pharmacy for reconciliation by study monitor, and then destruction or return to sponsor

Randomization:
There is no randomization
Randomization will be managed by the Investigator and the Research Pharmacy will be notified of treatment assignment in writing on drug order or via separate FAX
Randomization will be managed by the Research Pharmacy via an Interactive Voice Recognition System (IVRS)
Randomization will be generated by the sponsor or Investigator and managed by the Research Pharmacy via paper copy or on-line randomization method
Randomization code will be generated by the Research Pharmacy managed within the Research Pharmacy

Inventory will be handled by the Research Pharmacy using:
standard GCP compliant methods
Sponsor specific inventory forms
Sponsor specific inventory forms and IVRS

Drug Description:  Anti-Neoplastic Agent(s)?      Yes       No  
Study Drug: (include both investigational agents and FDA approved products)
Study drug provider:
Formulation: (How will drugs be supplied to the pharmacy?)
Capsules Tablet Vials Pre-Packaged For Dispensing
Bulk (Requires Packaging/Labeling/Dispensing)

Additional Items/Equip Required:      IV Pump    Injection supplies      Ordering Bulk Drug
Other:
Items/equipment provider:

Additional Info: 
Has Project been submitted to IRB?
       Yes       No  
Will study be submitted to the Clinical Trials Office?
       Yes       No  

Anticipated Start Date:
Approx duration:   
Estimated # of patients:
Where will patients be seen (Clinic location)?   
Are deliveries to hospital or clinic sites required?       Yes       No  
If yes, specify delivery location(s) (Building, Flr, Rm):
Are patient shipments required?       Yes       No  
If yes, will shipments need to be anonymous?       Yes       No  

Monitoring:
Investigator will monitor Research Pharmacy function directly without outside monitoring
Sponsor will not monitor Research Pharmacy function
Sponsor will monitor Research Pharmacy function
Monitoring performed by:      Sponsor      CRO/SRO      Other     
Monitoring Company Name/Div     
Monitor Name Phone:
Fax: E-mail:
The following number of outside monitoring visits are expected each year

Meetings:
Will there be a study start-up meeting for pharmacy to attend? Yes       No  
If yes, provide location, date & time (if known)
     
Will there be periodic study meetings for pharmacy to attend? Yes       No  
If yes, provide location, date & time (if known)

Updates and Closure:
Please notify the pharmacy of changes in study protocol and approval.
The pharmacy must also be notified when the study closes.


You will receive a Research Pharmacy Cost Estimate within 1-2 weeks.
**Complete and sign the Investigator Approval section, and return the signed copy to researchpharmacy@columbia.edu as an e-mail attachment or fax to 201-568-6148.

The Research Pharmacy will not provide services until the signed cost estimate and regulatory documents (IRB approval letter, 1572 form) have been received.

When you are ready to initiate the study, please notify the Research Pharmacist named on the cost estimate.

Thank you.
Form is not yet complete.  Do not yet forward information to Clinical Trials Office.
Form is complete.  Forward information to Clinical Trials Office.
 


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