Study start-up (SSU) is so much more than a one-time document management exercise. It’s a global, strategic operation that can get new drugs approved faster – and it’s ripe for innovation – from Site Selection to Site Activation and Site Training.
Many SSU tech solutions deployed by sponsors don’t deliver the results promised because they add burden without benefits to clinical research sites. The result? Site staff simply avoid using them.
When that happens, document exchange and tracking falls back to paper, email and Excel formats – with CRAs holding the processes together. The tools that were supposed to solve a problem become part of the problem – and consume preThe implementation and conduct of a study can be a complex process that involves a
team from various disciplines and multiple steps that are dependent on one another. This
document offers guidance for navigating the study start-up processcious clinical trial budget.
A successful clinical study start-up is a crucial first step and an important factor for the overall success of the trial. For this reason, SCRO has experienced study start-up teams, offering customized services depending on your needs, whether it be fuWhile the definition varies across companies, study startup typically includes the process of identifying and qualifying sites, collecting essential documents at the study and site level, and submitting these documents for ethics approval. Successful study startup requires coordination between sites, sponsors, and contract research organizations (CROs) to achieve critical milestones in a compliant manner.ll-service or single activities.
How to achieve better time management in EDC start up
Clinical data management requires strict time management processes, especially in study start up within an electronic data capture (EDC) system. Three steps that clinical data management teams can take to outline the planning and executing of each task that needs to be considered are as follows:
Make a List: Create a daily or weekly task list and schedule when each task will be completed. This strategy will assist you in maintaining focus and staying organized.
Set realist goals: Be realistic about what you can finish in the amount of time you have. When setting unrealistic goals, failure is almost certain to follow.
Explore time-saving techniques: Examples of techniques that could help save time include grouping similar tasks together or using a timer to stay focused.
To help get started, here is a list of EDC considerations for Study Start-Up deadlines:
Protocol finalization and study enrollment
Split go-live considerations
eCRF Specification meetings (this will ensure proper collaboration and minimize any back-and-forth communication)
EDC add-on modules (which will be required and need validation?)
ePRO/eCOA used with licensed questionnaires.
IRB requirements for add-on modules (eConsent/ePRO)
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/1Es9sPRKPUmJ377S2VrFtUdc6RI
CVNTub7-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. ApproVal
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.
