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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 goedgekeurde nieuwe/gewijzigde studiedocumenten van reeds lopende studies: vul het Notification form new study documents in.

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 approved new/changed study documents of registered trials: complete the Notification form new study documents.

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.     
|  Your name     
|  Your First Name     
|  Your mobile n°   
Phone number as +xx xxxxxxxxx (country code followed by space and phonenumber) eg. +32 93322111
 
|  Your e-mail address     
|  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 SIV slides     
Upload Contact list     
Upload IWRS manual     
Upload EDC manual     
Upload SmPC     
Upload Safety data sheet     
Upload Approval documents     
Upload Temperature excursion form (blank)     
Upload Complaint form (blank)     
Upload Other     
Link to Clinical Trials UZ Gent Teamssite (access automatically granted after completion of this form): Pharmacy Clinical Trials UZ Gent (Documents Initiation)     
|  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     
     
Access to an external study specific Teamsite (=protocolsite) (containing unblinded information) will automatically be granted to the UNBLINDED monitor after completion of this form. Make sure NOT to fill in BLINDED personnel!     
|  Clinical Research Organization     
     
|  Sponsor     
     
AMP/compassionate use applicable?     
For Medical Need Programs, please contact medicalneed.stalen@uzgent.be     
|  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     
Check your completed form (with extra attention to the name of the blinded and/or unblinded monitor) before submitting it     

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