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Study registration form Clinical Trials 

Dit aanmeldformulier is ENKEL bedoeld voor NIEUW aan te melden klinische studies en steeds voorafgaand aan een ingeplande apotheek initiatie. 
Aanpassingen tussen invullen van het formulier en apotheek initiatie, dienen tijdens IV besproken te worden.
Voor aanpassingen aan reeds lopende studies, neem contact op via pharmacy.clinicaltrials@uzgent.be.

Velden aangeduid met een rode lijn zijn verplicht in te vullen.

Alle informatie doorgestuurd via dit aanmeldformulier is enkel toegankelijk voor het actuele team van Apotheek Klinische Studies UZ Gent.

This registration form is intented to be used for NEW clinical studies ONLY and in order to prepare the pharmacy initiation. 
Amendments between completion of the form and pharmacy initiation, are to be discussed during IV.
For communication/amendments concerning ongoing studies, please mail to pharmacy.clinicaltrials@uzgent.be.

Fields indicated with a red line are mandatory.

Any information submitted through this registration form will be only accessible to the actual Pharmacy Clinical Trials team of UZ Gent.

     
Data are kept in an MFA secured environment to which only authorised persons have access.     
General 
|  Your name     
|  Your First Name     
|  Your mobile n°   
Phone number as +32 xxx/xx.xx.xx
 
|  Your e-mail address     
Upload documents 
|  Upload Pharmacy Manual     
|  Upload Investigator Brochure     
|  Upload Protocol     
Upload Confidentiality Agreement for External Monitors (signed by CRA)   
see external Teamsite Pharmacy Clinical Trials UZ Gent (Documents Initiation) – to sign by CRA!
  		 
Upload File Note Working Method (signed by CRA)   
see external Teamsite Pharmacy Clinical Trials UZ Gent (Documents Initiation) – to sign by CRA!
  		 
Upload Other     
Link to external general Teamsite (access automatically granted after completion of this form): Pharmacy Clinical Trials UZ Gent (Documents Initiation)     
General information study 
|  Protocol code   
protocol code as mentioned in study protocol
 
|  Title Study     
Acronym Study     
|  Therapeutic indication     
|  Setting     
|  Phase Study     
|  Blinding     
|  Site number     
|  Principal Investigator UZ Gent     
|  Medical Service UZ Gent     
UZ Gent study coordinator     
BLINDED Monitor     
     
UNBLINDED Monitor     
     
|  Clinical Research Organization     
     
|  Sponsor     
     
AMP/compassionate use applicable?     
For Medical Need Programs, please contact medicalneed.stalen@uzgent.be     
IMP 
|  Role of the pharmacy     
|  Name     
|  IMP type     
|  IMP class     
|  Delivery and invoicing     
|  Pharmaceutical form   
If not applicable (e.g. device study) or unknown: check "Other pharmaceutical form" and add n/a or TBD
 
Other pharmaceutical form?     
|  Dosage strength per unit   
e.g. 200 mg per capsule, 500 mg per pre-filled syringe,… If not applicable (e.g. device study) or unknown: add n/a or TBD
 
|  Number of units per box   
e.g. 20 capsules per bottle, 1 pre-filled syringe per box, 10 vials per box,… If not applicable (e.g. device study) or unknown: add n/a or TBD
 
|  Route of administration   
If not applicable (e.g. device study) or unknown: check "Not in the list" and add n/a or TBD
 
Not in the list     
|  Storage condition   
If not applicable (e.g. device study) or unknown: add n/a or TBD
 
Add an extra IMP     
Important 
Check your completed form (with extra attention to the name of the blinded and/or unblinded monitor) before submitting it     

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