This page is for Study Staff.

You can find and download ENFORCE study related document below,
• Protocol and protocol related documents
• Study specific logs
• Study specific worksheets
 

If you have further questions regarding the study documents, please contact study personnel via email: enforce.rigshospitalet@regionh.dk. 
 

Protocol, IC, Manualer og Dokumenter

• • ENFORCE Protocol v6.1 2022FEB07
• • ENFORCE add vacc DK IC v1.0 2022JAN25 Aalborg
• • ENFORCE add vacc DK IC v1.0 2022JAN25 Aarhus
• • ENFORCE add vacc DK IC v1.0 2022JAN25 Herlev
• • ENFORCE add vacc DK IC v1.0 2022JAN25 Hvidovre
• • ENFORCE add vacc DK IC v1.0 2022JAN25 Odense
• • ENFORCE add vacc DK IC v1.0 2022JAN25 Roskilde
• • ENFORCE Booster DK IC v1.0 2021OCT04 Aarhus
• • ENFORCE Booster DK IC v1.0 2021OCT04 Aalborg
• • ENFORCE Booster DK IC v1.0 2021OCT04 Roskilde
• • ENFORCE Booster DK IC v1.0 2021OCT04 Odense
• • ENFORCE Booster DK IC v1.0 2021OCT04 Hvidovre
• • ENFORCE Booster DK IC v1.0 2021OCT04 Herlev
• • ENFORCE Informed Consent v4, Aarhus 2020APR09
• • ENFORCE Informed Consent v4, Aalborg 2020APR09
• • ENFORCE Informed Consent v4, Roskilde 2020APR09
• • ENFORCE Informed Consent v4, Odense 2020APR09
• • ENFORCE Informed Consent v4, Hvidovre 2020APR09
• • ENFORCE Informed Consent v4, Herlev 2020APR09
• • ENFORCE PIM Protokol v5 Version 3.0 2021OCT05
• • ENFORCE Træningsslides til protokol v4 2021APR15
• • ENFORCE Træningsslides til protokol v5 2021SEP28
• • ENFORCE Træningsslides til protokol opdateringer 4.stik 2022FEB01
• • ENFORCE Site information Form 2020JAN08
• • ENFORCE Deltager-information v4, 2021APR09
• • ENFORCE Source Data Location Agreement v2, 2021MAR16
• • ENFORCE Subject Source Data Document V2 2021APR22
• • ENFORCE Subject Source Data Document Booster 2021OKT06
• • ENFORCE Subject Source Data Document V4 2022FEB17
• • ENFORCE_Subject Source Data Document_X_XC_V3_2022SEP28
•  

Study specific logs

• • ENFORCE Signature Log, Delegation and Training Log 2020JAN08
• • ENFORCE Subject Identification Log v2, 2021APR22
• • ENFORCE Subject Identification Log Booster 2021OKT06
• • ENFORCE Subject Identification Log add vacc v1 2022FEB16.pdf
• • ENFORCE Sub study 1 samples for future reseach - Subject Identification Log_v1_2021DEC06
• • ENFORCE Specimen Identification Log_2020JAN26
• • ENFORCE Specimen Shipping Log 2021JAN26
• • ENFORCE Cellular Immunity Sub Study Specimen Identification Log 2021JAN27
• • ENFORCE Cellular Immunity Sub Study Specimen Shipping Log 2021JAN22
• • ENFORCE Substudy 2 (Safety-AstraZeneca SSI) Specimen Identification Log 2021APR14
• • ENFORCE Substudy 2 (Safety-AstraZeneca SSI) Specimen Shipping log_2021APR14
• • ENFORCE Substudy 2 (Safety-AstraZeneca AUH) Specimen Identification Log_2021APR19
• • ENFORCE Substudy 2 (Safety-AstraZeneca AUH) Specimen Shipping Log_2021APR19.pdf
•  

Worksheets, Serious adverse event form (SAE) and Symptom Form

• • ENFORCE Worksheet Studiebesøg 1 2021NOV30
• • ENFORCE Worksheet GENTAGET Studiebesøg 1 2021MAJ10
• • ENFORCE Worksheet Substudie 2 (Safety) Studiebesøg 1C 2021NOV30
• • ENFORCE Worksheet Studiebesøg 2 2021NOV30
• • ENFORCE Worksheet Studiebesøg 3 2021NOV30
• • ENFORCE Worksheet Studiebesøg 4 2021NOV30
• • ENFORCE Worksheet Studiebesøg 5 2021DEC06
• • ENFORCE Worksheet Studiebesøg 6 2021DEC06
• • ENFORCE Worksheet Studiebesøg X 2021DEC06
• • ENFORCE Worksheet Studiebesøg Xc 2021DEC06
• • ENFORCE Worksheet Studiebesøg X4 2022FEB08
• • ENFORCE Worksheet Studiebesøg Xc4 2022FEB08
• • ENFORCE Worksheet Udeblivelse af Studiet 2021NOV02
• • ENFORCE Worksheet Serious Adverse Event 2021NOV30
• • ENFORCE Worksheet Site Transfer 2021MAJ10
• • ENFORCE Symptomskema for deltagere 2021JUN02
• • ENFORCE Symptomskema Booster 3A og 3B 2021SEP17
• • ENFORCE Symptomskema for deltagere 4A og 4B 2022FEB17