| SOP / Anhangtyp |
SOP-Titel |
Version |
letztes Review |
| |
|
|
|
| CIO-DM-001-00 |
Allgemeines Daten Management |
3.2 |
17.07.2024 |
| Template |
DM-001-01-Daten-Management-Anforderungsliste |
|
|
| CIO-DM-002-00 |
Werkzeug CRF Entwicklung zur Datenerhebung |
3.2 |
17.07.2024 |
| CIO-DM-003-00 |
Datenbank und eCRF Entwicklung |
3.2 |
17.07.2024 |
| CIO-DM-004-00 |
System-Validierung |
3.2
|
18.07.2024 |
| Template |
DM-004-01-Spezifikation Nutzeranforderungen |
|
|
| Template |
DM-004-02a-IQ-Testvorlage |
|
|
| Template |
DM-004-02b-IQ-Retestvorlage |
|
|
| Template |
DM-004-03a-OQ-Testvorlage |
|
|
| Template |
DM-004-03b-OQ-Retestvorlage |
|
|
| Template |
DM-004-04-PQ-Testvorlage |
|
|
| Template |
DM-004-05-Validierungsbericht-Vorlage |
|
|
| Template |
DM-004-06-Aenderungskontrolle-Vorlage |
|
|
| CIO-DM-005-00 |
Daten-Sicherheit |
3.2 |
18.07.2024 |
| Template |
CIO-DM-005-01-Template-Information_Asset_Register |
|
|
| Template |
CIO-DM-005-02-Example-Confidentiality_and_user_conduct_agreement |
|
|
| CIO-DM-006-00 |
Schulung |
3.2 |
19.07.2024 |
| Template |
CIO-DM-006-01-Template-Training_confirmation_form |
|
|
| CIO-DM-007-00 |
Daten-Management-Plan |
3.2 |
19.07.2024 |
| Template |
CIO-DM-007-01-Template-DMP |
|
|
| Beispiel |
DMP HCQ-Studie |
|
05.12.2018 |
| CIO-DM-008-00 |
Datenerhebung und Dateneingabe |
3.2 |
19.07.2024 |
| CIO-DM-009-00 |
Datenbereinigung |
3.2 |
23.07.2024 |
| Template |
CIO-DM-009-01-Template-Data_Clarification_Form |
|
|
| Template |
CIO-DM-009-02-Example-Data_Clarification_Form |
|
|
| CIO-DM-010-00 |
Datenkodierung |
3.2 |
23.07.2024 |
| CIO-DM-011-00 |
SAE-Abgleich |
3.2 |
23.07.2024 |
| Template |
CIO-DM-011-01-Template-SAE_Reconciliation_checklist |
|
|
| Example |
CIO-DM-011-02-Example-AE_SAE_workflow_description_german |
|
|
| CIO-DM-012-00 |
Daten-Nachverfolgung |
3.2 |
24.07.2024 |
| Template |
CIO-DM-012-01-Template-Batch_cover |
|
|
| Template |
CIO-DM-012-02-Template-Tracking_Log |
|
|
| CIO-DM-013-00 |
Daten-Transfer |
3.1 |
24.07.2024 |
| CIO-DM-014-00 |
IT-Support |
3.1 |
24.07.2024 |
| CIO-DM-015-00 |
Datenbank sperren |
3.2 |
24.07.2024 |
| Template |
CIO-DM-015-01-Template-Database_Lock_Checklist |
|
|
| Template |
CIO-DM-015-02-Template-Database_Lock_Approval |
|
|
| Template |
CIO-DM-015-03-Template-Database_Unlock_Approval |
|
|
| CIO-DM-016-00 |
Datenbankarchivierung |
3.2 |
25.07.2024 |
| |
CIO-DM-016-01-Template-Database_Archiving_Approval |
|
|
| |
CIO-DM-016-02-Work_Instruction-Database_ArchivingCIO-DM-016-02-Work_Instruction-Database_Archiving |
|
|