Data Management Updates

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Kristian Marsh
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1 Data Management Updates Jenny Darcy Data Management Aiance CRP Meeting, Thursday, November 1st, 2018

2 Presentation Objectives New staff Update on Ingres (JCCS) conversion project Fina IRB cosure at study termination Changes to the Overdue Materia Report--PDF fie now avaiabe Data freeze Rave tips

3 Data Management New Supervisors 10/25/18

4 Data Management New Data Managers - Leve III 10/25/18

5 Data Management New Data Managers Leve II 10/25/18

6 Ingres to Rave Conversion - Retirement Target competion: December Tota Project Study Scope for the Aiance 32 - Aiance Studies are targeted for Competion 6 - Studies have been Terminated (Record Retention) since the start of the project in January Studies that wi move to competed status by the end of June Aiance Studies remain that are targeted for Conversion to Rave Aiance Studies targeted for conversion in eary 2019: N0577 Fu Buid Conversion Z1071 Partia Buid Conversion (Foow-up Ony) N107C Partia Buid Conversion (Foow-up Ony) * * Conversion decision pending outcome of Foow-up activity in eary 2019

7 IRB Cosure Question When is the appropriate time to cose a study to your IRB? When the termination memo is posted on the Aiance website.

8 Updated Overdue Materia Update Updates requested by the CRP Committee at the May 2018 Aiance Meeting Key Updates Avaiabe in both pdf and exce on the Aiance website Data coapsed into 1 report regardess of number of days overdue and incudes expected forms/queries in the next 30 days Additiona data provided incuding both the target and overdue form date with definitions provided on the spreadsheet Summary report for Member PIs in deveopment

11 Updated Overdue Materia Reports Exampe of the CRP exce spreadsheet 10/25/18

12 Data Management Data Freeze Piot (A and A021501) Effective August 15, 2018 Achieve the highest data management standards Provides awareness of changes to data after key reviews are competed by DM Key data fieds to be ocked after review competed Eigibiity Case Evauation Foow-up compete If corrections are required post-ock Sites wi need to contact the Data Manager to unock Site and DM feedback to be obtained at the end of piot 10/25/18

13 Rave Reminders Fi Patient Status forms out at the end of the cyce Patient Status form is what drives Rave navigation and target dates for subsequent cyces If you need hep with foder/form ro out, contact your Data Manager Pease update your institution contact, it aows us to query the proper contact

14 Query Responses There are two types of entry fieds avaiabe with most types of queries. User Response Fied: A free-text fied that can be used to provide further carification, to specify when data is not avaiabe, or to provide a response (when required) to a DM-generated query (aso caed query response box). Data Entry Fied: Where data requested for that fied shoud be provided, when avaiabe. Common Query: Pease provide your response in the data fied, not in the query response box.

System-Generated Queries Exampes woud be non-conformant data, data fied is required/not required, future date entered, study-specific requirements, etc.

15 System-Generated Queries Exampes woud be non-conformant data, data fied is required/not required, future date entered, study-specific requirements, etc. Log ines with open queries wi appear in ight and/or dark pink on the ecrf. These queries generate once the form is saved and wi have the corresponding open query icon on the og ine in which the query appears. *Pease review ecrfs for system-generated queries once saved.

16 System-Generated Queries Do not require a query response if the query can be resoved without further carification to DM. Once the data is entered/issue resoved, the systemgenerated query box wi shade out, indicating a response is not required, as ong as response is provided in the data entry fied first (prior to responding in user-response fied). User is now unabe to type in the shaded out user-response fied, as response is no onger required.

17 DM-Generated Queries These queries are issued upon review of the data, when further carification or data changes are required. Most often require a query response in the user-response box (often a response of updated wi suffice when no further carification is need and data can be updated). Once a query response is entered/saved, the DM receives a notification in their Answered Queries, which prompts the DM to review the query and either cose it out or re-query if additiona carification is needed. Query Icon wi appear on the ecrf unti DM coses the query out on their end.

18 Query Responses When data changes are required, responses shoud be amended in the data fied and a response shoud be entered in the query response box. Providing ony a response in the query response box wi resut in requery, uness further carification is provided. A response was entered and saved in the user-response box, but there was no data provided in the data entry fied. DM wi re-query. There is no data saved in the data fied.

19 Query Responses Site was re-queried to provide their response in the data entry fied. A response of updated in the user-response fied notifies DM of response. Query is resoved. Data is avaiabe in the data entry fied on the right side of the screen.

20 Query Responses Sometimes responses are provided where they are not required. Free-text fieds shoud have data deeted and remain empty. Drop Down menus shoud have the top empty seection with the seected.

21 Query Responses To save this data fied bank, cick on the itte back dot corresponding to a Yes response to remove it. When saved correcty, the data fied wi ony indicate the icon indicating data was changed, with no data present in the Data Fied

22 Query Responses Pease do not respond to queries with pending or wi ook into, etc. as this wi resut in a requery from the DM. The DM cannot cose out the query without resoution/carification and are imited in the abiity to track these issues outside of re-issuing a query. If the query were to be cosed out pending response, it no onger appears anywhere in the Task Manager and is no onger on the radar for the DM or CRA to compete.

Query Responses vs. Comments Pease note that query responses in the query response boxes are not aways avaiabe to the statistica team when doing their anaysis.

23 Query Responses vs. Comments Pease note that query responses in the query response boxes are not aways avaiabe to the statistica team when doing their anaysis. If there is pertinent information that needs to be shared with and/or considered by the study team, pease use the Comments section instead of in the query response box.

24 Query Responses vs. Comments The Comments section can be used in repacement of a response, as in the previous side, or in addition to a response, as iustrated on this side.

25 Thank you!

Importance of Timely Data Submission

Importance of Timely Data Submission Importance of Timey Data Submission Shauna Himan Mayo Cinic CRP Information Session, November 2 nd, 2017 Presentation Objectives Iustrate the importance of data submission timeiness Communicate the status