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DQSP - Coggle Diagram
DQSP
Initial Run
Step 1: DQSP Task received
& assigned
Step 2: Preparation in Marvel
2.1 Ask for access rights
2.2 Check documents - aCRF
aCRF (define, SDRG): /Surveillance/SDTMrev/1st/prod/outputs/yyyy-mm-dd
2.4 Check DQSPlan version in eTrial & MARVEL
2.5 Check data(clinical datasets)
2.6 Create a new subtask DQSP
2.3 Check documents - aCRF
protocol: <study>/documents/Protocol
2.7 Create all links after new subtask created
Step 4: Edit dqsp_checks program (rename from dqsp_checks_auto)
4.1 Fill parameters
4.2 Check and comment out the no need checks
Step 5: Implement study-specific checks. Refer study specific pool document in Home (sharepoint.com)
5.1 Program code
5.2 Compile into macro catalog
Step 6: Run dqsp_checks
6.1 Edit value sets
6.2 Submit program
Step 7: Check log and output
Step 8: Check full domain
Step 10: Ask for QC by providing QC document
10.1 Export pre-QC document
Location: /Surveillance/DQSP/1st/dev/outputs
10.2 Update “QC status” and applicable comments in "programmer Comments”
10.3 Send the QC document with location of program, outputs, log to QC programmer
Step 11: Update the program until no further comments from QC (email confirmation)
Step 12: Upload QC document to X drive
Location: X:\01 Programming Team\01 Oversight\01 KPI
Step 13: Move the dqsp_checks, catalog, config to prod and run in prod
Step 14: Run DQSP new layout
14.1 Compile 2 macros in dev
14.2 Edit parameters in NL_dqsp.sas in dev
14.3 Run NL_dqsp.sas in dev
14.4 Check log
14.6 Run NL_dqsp in prod
14.7 Update parameters for R program in dev
14.8 Move R program to prod
14.5 Move NL_dqsp and catalog to prod
14.9 Run R program only in prod
14.10 Check the re-formatted file in prod
Step 15: Inform data manager
Step 17: Run oversight tool
Step 9: Update DQSP issue log if required
Step 16: Update in eTrial
Step 3: Copy and run programming_dev
Non initial Run
Step 1: Receive notification and be assigned
Step 2: Preparation in MARVEL
Step 3: Copy and run programming_dev
Step 4: Any check not implemented previously can be implemented now or any new check added in plan to be implemented now?
a. Yes
5a. Edit dqsp_checks program (rename from dqsp_checks_auto)
6a. Implement any new study-specific checks
7a. Program code
8a. Compile into macro catalog
b. No
9a. 5b. Run dqsp_checks
9a.1 5b.1 Edit value sets
9a.2 5b.2 Submit program
Step 11: Check full domain
Step 12: Any update to dqsp_checks program
a. Yes
12a. Update DQSP issue log if required
13a. Ask for QC by providing QC document
14a. Export pre-QC document
Location: /Surveillance/DQSP/1st/dev/outputs
15a. Update “QC status” and applicable comments in "programmer Comments”
16a. Send the QC document with location of program, outputs, log to QC programmer
17a. Update the program until no further comments from QC (email confirmation)
1 more item...
b. No
12b. Update DQSP issue log if required
18a. 13b. Move the dqsp_checks, catalog, config to prod and run in prod
19a. 14b. Upload QC document to X drive
Location: X:\01 Programming Team\01 Oversight\01 KPI
20a. 15b. Run DQSP new layout
20.1a. 15.1b. Compile 2 macros in dev
20.2a. 15.2b. Edit parameters in NL_dqsp.sas in dev
20.3a. 15.3b. Run NL_dqsp.sas in dev
20.4a. 15.4b. Check log
20.5a. 15.5b. Move NL_dqsp and catalog to prod
20.6a. 15.6b. Run NL_dqsp in prod
20.7a. 15.7b. Update parameters for R program in dev
20.8a. 15.8b. Move R program to prod
20.10a. 15.10b. Check the re-formatted file in prod
21a. 16b. Inform data manager
22a. 17b. Update in eTrial
1 more item...
20.9a. 15.9b. Run R program only in prod
Step 10: Check log and output