Study Documents
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