Is the study using AIS-SAP Integration for 16 Yes No If yes, provide the study name to CTSU to setup the TSDV TSDV based on-site auditing? flag in RSS. LPO should use Rave ALS version 5.2 or above. ALS 5.2 will add a question the Subject identified for audit” to “Is the Information NCI Reporting” form. AIS-SAP “Patient integration process populates this above question to or “Yes” “No” Set up two "Field Rules” in TSDV Configuration to move the subjects between the two Tiers (No Forms and Audit Tier). After the setup of TSDV Rules” is complete, if audit “Field question on Information for NCI Reporting” “Patient form is set to the patient is moved into the Audit “Yes” tier in Rave so that TSDV can be captured. If it is set to the patient is moved to the Forms” tier from “No” “No tier” in Rave “Audit After audit is scheduled in AIS, spot check the following in Rave/iMedidata: 1. The cross group auditors and volunteer auditors have been invited for studies where TSDV has been set up. 2. Auditable Patients show up in the “Requires Verification” under Summary” in Rave. “Task After Audit is complete, spot check the following in Rave: 1. The Rave access has been revoked for group auditors and voluntary auditors. 2. Complete Audit Patients do not show up in the Verification” under Summary” in Rave. “Requires “Task
16 Is the study using AIS-SAP Integration for TSDV based on-site auditing? Yes No If yes, provide the study name to CTSU to setup the TSDV flag in RSS. LPO should use Rave ALS version 5.2 or above. ALS 5.2 will add a question “Is the Subject identified for audit” to the “Patient Information NCI Reporting” form. AIS-SAP integration process populates this above question to “Yes” or “No” Set up two "Field Rules” in TSDV Configuration to move the subjects between the two Tiers (No Forms and Audit Tier). After the setup of TSDV “Field Rules” is complete, if audit question on “Patient Information for NCI Reporting” form is set to “Yes” the patient is moved into the Audit tier in Rave so that TSDV can be captured. If it is set to “No” the patient is moved to the “No Forms” tier from “Audit tier” in Rave After audit is scheduled in AIS, spot check the following in Rave/iMedidata: 1. The cross group auditors and volunteer auditors have been invited for studies where TSDV has been set up. 2. Auditable Patients show up in the “Requires Verification” under “Task Summary” in Rave. After Audit is complete, spot check the following in Rave: 1. The Rave access has been revoked for group auditors and voluntary auditors. 2. Complete Audit Patients do not show up in the “Requires Verification” under “Task Summary” in Rave.