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Notification form new study documents 
Dit meldingsformulier is ENKEL bedoeld voor goedgekeurde nieuwe/gewijzigde studiedocumenten van een REEDS LOPENDE studie. Voor nieuw aan te melden klinische studies: vul het Study registration form Clinical Trials in.
Velden aangeduid met een rode lijn zijn verplicht in te vullen. 
Na het verzenden van het meldingsformulier wordt een automatische bevestiging verzonden naar het opgegeven e-mailadres. 
Alle informatie doorgestuurd via dit formulier is enkel toegankelijk voor het actuele team van Apotheek Klinische Studies UZ Gent.
Wijzigingen aan de gerelateerde apotheekprotocollen worden uitgevoerd door een getrainde apotheker zo snel als redelijkerwijs mogelijk. Alle apotheek gerelateerde studietaken worden voortdurend uitgevoerd volgens de meest recente versie van de studiedocumenten, na hertraining van alle betrokken apothekers Klinische Studies (groepstraining of zelfstudie). Tijdige hertraining is gegarandeerd zonder specifieke documentatie op een training log, tenzij opgelegd door de sponsor.      
This notification form is ONLY intended to be used for approved new/changed study documents of an ONGOING trial. For new clinical studies: complete the Study registration form Clinical Trials.
Fields indicated with a red line are mandatory.
After submitting this notification form, an automatic confirmation will be sent to the e-mail address provided.
Any information submitted through this notification form will only be accessible to the actual Pharmacy Clinical Trials team of UZ Gent.
Adaptations to the related pharmacy protocols are executed by a trained pharmacist as soon as reasonably possible. All pharmacy related study tasks are continuously performed according to the most recent version of study documents, after retraining of all involved pharmacists Clinical Trials (multiple attendee training or self-study). Retraining in a timely manner is guaranteed without specific documentation on a training log, unless imposed by the sponsor.     
Documents are kept on an MFA secured study specific Teams protocolsite to which only authorised persons have access.      
General 
|  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     
General information study 
|  Protocol code   
Protocol code as mentioned in study protocol
 
      All ongoing trials in the pharmacy of UZ Gent are listed. If the protocol code is not in list, please contact pharmacy.clinicaltrials@uzgent.be
Access to external studyspecific Teamsite (=protocolsite) 
UNBLINDED Monitor     
     
Extra acces needed for     
     
Access to the external study specific Teamsite (=protocolsite) will automatically be granted to the UNBLINDED monitor or the extra person filled in above after completion of this form. Please note this protocolsite may contain UNBLINDED information.     
New study documents 
We kindly request that each individual document be uploaded to the appropriate folder.

Please do not send any documents that are not relevant to the pharmacy (f.e. informed consents).

The use of the possibility to upload Other documents should be limited to what is necessary.     
Upload new Contact list?     
Upload new Investigator brochure?     
Upload new Protocol?     
Upload new Pharmacy manual?     
Upload new IWRS manual?     
Upload Follow-up or Close-out letter?     
Upload Retraining material?     
|  Documentation of retraining required on a training log?   
If ‘Yes’, training is documented on an internal training log (signed off by the pharmacist who retrained the rest of the staff)
 
|  Acknowledgement of receipt to be signed by a pharmacist?     
Upload new Other documents?     
Check your completed form (with extra attention to the correct protocol code) before submitting it      

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