Start-Up Operations for Clinical Studies

The Study Start-Up (SSU) phase is the first and most critical stage of a clinical trial. It involves all tasks necessary to prepare and activate study sites for participant enrollment. The goal of this phase is to ensure that every site is fully equipped, trained, and compliant before the study begins.

1. Study start up [email protected] | https://clinicalda.blogspot.com

2. Study start up The study start-up phase is a critical stage in clinical data management that involves planning and preparation for the data collection, processing, and analysis of data in a clinical trial. This phase has immense downstream impact on study conduct and closeout stages & clean study start-up activities can save whole lot of time, money & rework.

3. We can Categorize study startup activities in to 3 main headings. 𝟭. 𝗘𝗗𝗖 𝗗𝗮𝘁𝗮𝗯𝗮𝘀𝗲 𝗗𝗲𝘀𝗶𝗴𝗻 𝟮. 𝗨𝗔𝗧 𝗧𝗲𝘀𝘁𝗶𝗻𝗴 𝟯. 𝗠𝗲𝗲𝘁𝗶𝗻𝗴𝘀 Let's Learn them one by one:

4. EDC Database EDC (Electronic Data Capture) is an essential component of study start-up, which allows clinical trial data to be collected, managed, and analysed in a more efficient and accurate way.

5. 1.Clear understanding of study requirements from protocol All the data that needs to be collected in the study has to be mapped back to study protocol. So clear understanding of study data requirements from the protocol crucial. This link has detailed explanation about how Data Manager need to review Study protocol LINK: https://docs.google.com/presentation/d/1Es9sPRKPUmJ377S2VrFtUdc6RICVNTub7-O2juJuz9E/edit#slide=id.p

6. 2.Inputs from clinical study team: Here mainly we are focusing on the inputs from study team who brings the wealth of their experience in conducting clinical trials to enhance the study data collection steps or to avoid major issues. Also inputs regarding how study endpoints needs to be meet with right data collection, what are the challenges & risks in conducting the study

7. 3.Case Report Form(CRF): The database must be designed to ensure data accuracy, consistency, and completeness. It should also be able to handle large volumes of data, have built-in data validation checks, and ensure data privacy and security.

8. 4.Database Design The database must be designed to ensure data accuracy, consistency, and completeness. It should also be able to handle large volumes of data, have built-in data validation checks, and ensure data privacy and security.

9. 6.Medical coding,Protocol deviation and vendor site set up Medical coding is an important component of EDC that involves assigning standardized codes to medical terms, procedures, and diagnoses. Similarly, PD's & all the required vendor data setup needs to included into EDC.

10. 5.Edit check programming To ensure data accuracy and completeness, the EDC system should have built-in data validation checks and edit checks. Edit checks are programmed to detect logical errors in the data. We use Edit Check spec to guide the programming team,

11. UAT clinical database UAT is part of validation done by end users to ensure the database is built as per the study requirements. Before go live end users will be sponsors & internal testing team. 𝗣𝘂𝗿𝗽𝗼𝘀𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗨𝗔𝗧 𝗶𝗻𝗰𝗹𝘂𝗱𝗲 1. To identify any issues or defects & address them before database go live 2. To gain feedback from end-users about the system's functionality, usability, and performance. 3. To document the validation steps for that serves as evidence of testing.

12. Important components of UAT 1. UAT Plan 2. Test Cases 3. Mock data for testing 4. Documentation 5. Appro Val

13. UAT Plan UAT Plan is the heart of the testing, which defines what components of databases are tested ( eCRF’s edit checks etc). Clear UAT plan serves a long way in successful UAT. Test cases An experience clinical data managers can come up a multiple scenarios to be tested for a given data point on the eCRF’s, for example – on lab forms test cases need to written to test scenarios for blank data, values below or above the normal limits, checking for correct units etc.

14. Mock data entry and testing Mock data entry gives a real time experience for database tester to clearly test the eCRF’s or Edit checks – as it simulate the live data entry. Clear UAT testing documentations Missing / incomplete UAT documentation is one of the major audit findings one notice in study startup phase. Ensure to clear document UAT testing steps, checks that are failed, passed, and next round of testing for failed checks.

15. Approvals & communication Proper closure of UAT is required to move ahead with go live of the study / PPC which includes complete approvals from database testers, data managers and study lead. Ensure to keep a clear, open communication with study team about the UAT proceedings.

16. What components are tested during UAT 𝟭. 𝗲𝗖𝗥𝗙'𝘀 : During UAT, eCRF functionality is tested for the completeness & accuracy of the entered data. Also dynamic visits and eCRF's are tested as well. 𝟮. 𝗘𝗱𝗶𝘁 𝗰𝗵𝗲𝗰𝗸𝘀: Edit checks are automated validation rules that flag potential errors or discrepancies in the data collected on the eCRFs. During UAT, edit check are tested to ensure that they are triggered correctly and are accurately detecting data anomalies with accurate queries.

17. 𝟯. 𝗖𝗼𝗱𝗶𝗻𝗴: Coding refers to the process of assigning standardized medical codes to clinical trial data, such as adverse events or medications. During UAT, coding functionality is tested to ensure that the correct codes are assigned to the correct data in AE, MH & CM forms. 𝟰. 𝗣𝗿𝗼𝘁𝗼𝗰𝗼𝗹 𝗗𝗲𝘃𝗶𝗮𝘁𝗶𝗼𝗻𝘀 (𝗣𝗗'𝘀) are events that occur during a clinical trial that deviate from the study protocol. During UAT, PD tracking functionality is tested to ensure that deviations are being captured and documented accurately.

18. 𝟱. 𝗜𝗩𝗥𝗦/𝗜𝗪𝗥𝗦 𝘀𝗲𝘁𝘂𝗽: 𝗜nteractive Voice Response Systems (IVRS) and Interactive Web Response Systems (IWRS) are used to manage clinical trial supplies and randomization. During UAT, IVRS/IWRS functionality is tested to ensure that randomization is being performed correctly and that supplies are being tracked and managed accurately. 𝟲. 𝗩𝗲𝗻𝗱𝗼𝗿 𝗗𝗮𝘁𝗮 𝘀𝗲𝘁𝘂𝗽: During clinical trials, vendors may be contracted to provide data management services or technology platforms. During UAT, vendor data setup is tested to ensure that data is being transferred and managed accurately between the study team and the vendor.