Oncology Annotations DFD
PC Console > Annotations
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Study Team: DocuSign approved? | Field to identify whether a study has been approved to utilize DocuSign for econsenting |
Not Required Select 'Yes' if the IRB has approved the use of DocuSign for econsenting |
PC Console edit / Regulatory Coordinator | No |
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Study Team: EMC Rejected? | Field to identify whether the use of EMC has been rejected by the study sponsor. |
Not Required Select 'Yes' if the study sponsor has requested use of the EMC for this protocol. |
PC Console edit / Protocol Administrative Coordinator | No |
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Study Team: EPOT Study Portfolio | Field to identify which portfolio the protocol has been assigned to within Early Phase Oncology Therapeutics (EPOT) disease team. |
Not Required Select the appropriate portfolio from the drop down menu for this protocol. |
PC Console edit / EPOT Study Team | No |
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| eBinders: Select the binder type | Field to identify the type of eBinder template to create for the study. |
Required Select the appropriate binder types per the binder type definitions |
PC Console edit / Regulatory Coordinator | No |
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Data and Safety Monitoring Board: Does this study have an external DSMB (or equivalent)? | Non-UW entity (e.g., sponsor/CRO, NCI) is responsible for monitoring study data. |
Not Required Oncology: Select 'Yes' if external DSMB Non-oncology: Not used |
PC Console edit / Regulatory Coordinator | No |
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Data and Safety Monitoring Board: With what frequency does the external DSMB meet? | The frequency the external DSMB reviews occur. |
Not Required Oncology: Select frequency Non-oncology: Not used |
PC Console edit / Regulatory Coordinator | No |
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Data and Safety Monitoring Board: Other, specify |
Not Required Oncology: Provide additional comments if frequency is other Non-oncology: Not used |
PC Console edit / Regulatory Coordinator | No |
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Data and Safety Monitoring Board: What is the current status of the external DSMB? | Status of the external DSMB. |
Not Required Oncology: Select status Non-oncology: Not used |
PC Console edit / Regulatory Coordinator | No |
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Administrator Use: DT4 - manual add study |
Not Required Oncology: Select 'Yes' if manual add study Non-oncology: Not used |
PC Console edit / PRMC Coordinator | No |
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Administrator Use: DT4 - comments |
Not Required Oncology: Provide additional comment as to why study needs manual addition to DT4 Non-oncology: Not used |
PC Console edit / PRMC Coordinator | No |
| Field Name | Definition | Requirement Entry Instructions |
Responsible for Entry | QA |
|---|---|---|---|---|
| Administrator Use: CTRAC Involvement |
Not Required Oncology:Select 'Yes' if CTRAC involvement Non-oncology: Not used |
PC Console edit / PRMC Coordinator | No |