Understanding source data verification

When no SDV is required in a study

In some cases. you will not require any level of SDV. For example, if you use Oracle Clinical One Platform primarily for randomization and trial supply management, SDV isn't necessary.

If your study doesn't require SDV:

Study manager: In a study's settings, select No for the Allow SDV in Study setting
Study designer: When selecting a question in a form, you don't have to switch on any of the Source Data Verification toggles
Clinical Research Associate (CRA): You don't have anything to verify in the study

When full SDV is required in a study

Full SDV means you want all data which can be entered by a user in your study to be verified, without exception.

Study manager: In a study's settings, select Yes for the Allow SDV in Study setting. Additionally, select 100% for the Amount of SDV setting
Study designer: you do no need to change SDV settings at the question level for full SDV.
CRA: You must verify everything in a study: all questions, all forms, and all completed visits. You will see check boxes for all items and questions

When targeted SDV is required in a study

Targeted SDV requires a bit more work. In this case, you must consider the amount of SDV (what percentage of the data should be checked and for which subjects). You must also consider which questions should be marked for Source Data Verification. In addition, you must decide if you want to allow the monitor (CRA) to verify data that is not specifically targeted for SDV.

When targeted SDV is required in a study:

Study manager:
- In a study's settings, select Yes for the Allow SDV in Study setting. Because you now want targeted SDV (not full SDV), select Targeted SDV for the Amount of SDV setting. For Allow SDV Overrides, you can select Yes to allow the CRA to verify any data, even data that is not specifically marked for targeted SDV in study design, or No to prohibit verification of data that is not specifically marked for SDV.
- On the same tab, create a targeted source data verification strategy where you specify the subject count for initial subjects associated with a site whose data must be verified (expressed in numbers) and the remaining subjects whose data must be verified at a site (expressed in percentages). For each of these subject groups, specify the SDV Type: 100% SDV or SDV for All Subjects & Critical Variables
Note:
Initial subjects at a site represent either the Active or Completed subjects who have visits which have been started.
Study designer: Work with the study management team to decide which questions should be source data verified for all subjects (set the SDV for All Subjects toggle) and which questions should be source data verified only for specified subjects (set the Critical Variables (Targeted SDV) toggle).

Note:
Questions with neither toggle set will only require verification if 100% SDV is chosen for the subject subset in the strategy.

CRA: Depending on the combination of settings that a study manager and study designer have configured, here's what you'll see in your study:

Table 8-1 SDV types selected by study managers

Allow SDV overrides	100% SDV	SDV for All Subjects & Critical Variables	Question is not marked in study design
Y	You must verify all completed visits, forms, and questions for the subjects specified in the Subject Count column, whether they were specifically marked by a study designer or not. Outlined checkboxes appear for all questions and items.	You must verify data depending on what the study designer specifically marked in the form. Questions and items marked in study design as SDV for All Subjects must be verified for all subjects in a study, including the specified subjects in the Subject Count column. Questions and items marked in study design as Critical Variables (Targeted SDV) must be verified only for the number of subjects specified in the Subject Count column. Outlined checkboxes appear for all questions and items specifically marked in study design. For questions that aren't specifically marked for SDV, regular checkboxes appear. It's up to you whether you choose to verify them or not.	Check boxes are shown, you can verify data at your discretion
N	Data must be verified for all specified subjects. Outlined checkboxes appear for all questions and items	Data must be verified for all specified subjects based on the questions marked by a study designer. For questions marked in study design as SDV for all Subjects and Critical Variables (Targeted SDV), outlined checkboxes appear. Any question that isn't specifically marked by a study designer will not show any kind of checkbox.	No checkboxes appear for these questions, no verification is allowed

Allow SDV overrides

100% SDV

SDV for All Subjects & Critical Variables

Question is not marked in study design

Y

You must verify all completed visits, forms, and questions for the subjects specified in the Subject Count column, whether they were specifically marked by a study designer or not.

Outlined checkboxes appear for all questions and items.

You must verify data depending on what the study designer specifically marked in the form.

Questions and items marked in study design as SDV for All Subjects must be verified for all subjects in a study, including the specified subjects in the Subject Count column.

Questions and items marked in study design as Critical Variables (Targeted SDV) must be verified only for the number of subjects specified in the Subject Count column.

Outlined checkboxes appear for all questions and items specifically marked in study design. For questions that aren't specifically marked for SDV, regular checkboxes appear. It's up to you whether you choose to verify them or not.

Check boxes are shown, you can verify data at your discretion

N

Data must be verified for all specified subjects.

Outlined checkboxes appear for all questions and items

Data must be verified for all specified subjects based on the questions marked by a study designer. For questions marked in study design as SDV for all Subjects and Critical Variables (Targeted SDV), outlined checkboxes appear. Any question that isn't specifically marked by a study designer will not show any kind of checkbox.

No checkboxes appear for these questions, no verification is allowed

Note:

The Initial Subjects are selected as they are screened, until the number specified in the Source Data Verification Settings has been reached. From there on, the Remaining Subjects are selected randomly based on the percentage specified.

Use cases

Forms, visits, or subjects with a status of SDV Complete or SDV Not Required can change status to SDV Required. This happens if questions requiring SDV are updated through a change in SDV settings or as a result of a subject being selected for SDV, in line with the SDV strategy. This can also happen if a dynamic form or question is triggered after verification is completed for the visit, where at least one question requires verification.

Note:
Once a subject has been selected for SDV and the strategy changes, thus reducing the number of subjects requiring SDV, the subject can no longer be deselected. The new strategy will only apply to newly entered subjects.
Each of the verification records in the Visit History will be attributed to the user who has performed verification.

Note:
If the SDV requirements of a study change, the verification records will be attributed to AutoSDV.
The number of questions requiring SDV may decrease if a study manager changes the SDV Strategy from 100% to Targeted SDV. This can change the status of a visit from SDV Required to Verified. The record added to the Visit History will feature the time when the SDV status was updated; it will also be attributed to AutoSDV.
A visit can receive a status of Unverified if it was partially verified, then the verified data changed.
If a visit was verified partially prior to the Oracle Clinical One Platform release 22.4 and a site user changes data on a verified question (thus causing said question to receive a status of Verification Required), then the visit will now receive a status of Unverified instead of Verification Required. This will change once a user opens any visit for the subject.
Whenever data labeled as Data Classified requires verification, it will be taken into account when calculating the status of a visit. This could mean that a visit may have a status of Verification Required or Unverified, even though a user may not be able to see the Data Classified question that requires verification. In other words, a user may see all questions of a visit as Verified, although the overall status of the visit is either Verification Required or Unverified. For more information about Data Classified questions, see Define data classifications for a hidden question

Caution:

Unblinded data may be inferred by blinded users during the verification process, even when a question is hidden. Take this into consideration when creating the SDV strategy and when specifying this type of questions to require SDV.

No SDV Required visits are identifiable through the absence of any SDV-related icons. Once any of the following actions occur, the status is updated as applicable:
- At least one question is verified.
- At least one question is unverified due to data change.
- A subject previously with a status of No SDV Required is selected for inclusion in the SDV pool.
- A user opens a visit for a subject for the first time after the Oracle Clinical One Platform release 22.4.
Note:
when using the SDV status filter, all visits with a status of Never Verified will be included among the results.