Study Documents
You can find and download PreVent-ACaLL study related document below.If you have further questions please contact principal investigator Carsten Utoft Niemann, MD, PhD, carsten.utoft.niemann@regionh.dk or chip-prevent.rigshospitalet@regionh.dk.
PreVent-ACaLL Protocol v2.0
PreVent-ACaLL Amendment to Protocol v2.0
PreVent-ACaLL Informed Consent Master v3.0 (English)
PreVent-ACaLL Informed Consent Prescreening Master v2.0 (English)
PreVent-ACaLL Schedule of Assessments v5.0
PreVent-ACaLL Laboratory Manual for sites v4.0
PreVent-ACaLL Laboratory Manual for local central labs v3.0
PreVent-ACaLL Pharmacy Manual v4.0
PreVent-ACaLL REDCap Guide v3.0
PreVent-ACaLL Initiation Flowchart
PreVent-ACaLL Instruction - Pre-screening, screening and randomization
PreVent-ACaLL Instruction - Enrolment procedure
PreVent-ACaLL Instruction - Collection of study samples
PreVent-ACaLL Instruction - How to handle AE and SAEs v2.0
PreVent-ACaLL Instruction - Reporting of protocol deviations
IWCLL Guideline (Hallek et al. 2018)
CTCAE (latest version)
PreVent-ACaLL Amendment to Protocol v2.0
PreVent-ACaLL Informed Consent Master v3.0 (English)
PreVent-ACaLL Informed Consent Prescreening Master v2.0 (English)
PreVent-ACaLL Schedule of Assessments v5.0
PreVent-ACaLL Laboratory Manual for sites v4.0
PreVent-ACaLL Laboratory Manual for local central labs v3.0
PreVent-ACaLL Pharmacy Manual v4.0
PreVent-ACaLL REDCap Guide v3.0
PreVent-ACaLL Initiation Flowchart
PreVent-ACaLL Instruction - Pre-screening, screening and randomization
PreVent-ACaLL Instruction - Enrolment procedure
PreVent-ACaLL Instruction - Collection of study samples
PreVent-ACaLL Instruction - How to handle AE and SAEs v2.0
PreVent-ACaLL Instruction - Reporting of protocol deviations
IWCLL Guideline (Hallek et al. 2018)
CTCAE (latest version)