Page Comparison

All of a subject's adverse events are displayed on the Adverse Events tab of the Subject Overview page
Adverse Events that are not resolved are highlighted red
A PDF report of all adverse events for the project can be viewed/printed for a desired date range
Limitations
- The variables cannot be modified
- The report cannot be modified
An alternate option to using the StudyTRAX Studytrax Adverse Events feature is to create a variable group with your custom variables and attach the variable group to a non-fixed interval

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A Medications tab is displayed on the Subject Overview page where all of a subject's medications are visible
Medications are selected from a list so they do not have to be typed
Medications that are available for selection must be added or imported into the central list
Medications in the central list must include:
- Trade Name
- Generic Name
- Code (a unique identifier for the medication)
- Unit of Measure
When Medications are entered for a subject they include:
- Medication Name - selected from the list
- Begin Date - must be entered in full date format - mm/dd/yyyy
- End Date - optional but if entered must be in full date format - mm/dd/yyyy
- Dose - must be entered in the unit of measure specified for the medication in the central list
- # / Day - must be entered as a whole number although 0 can be used
- Notes - an optional field
Data Sets
- Medication Groups can be created to define dose equivalenc scales for related medications
- Medication Groups can be exported in one column of a data set
- Medication Group Dosage and Medication Grouop Group Exposure (has ever taken) can be exported for a medication group
- Medication Dosage and Medication Exposure (has ever taken) can be exported for medications that are assigned to the project
  - Has Ever Taken: Outputs a 0 (No) or 1 (Yes) if the subject has ever taken the medication
  - Dosage: Outputs the dosage at an encounter based on the begin/end date of the medication and the date of the encounter
Limitations
- The subject medication fields cannot be modified
- Only medications assigned to a project can be exported through data sets
  Tip
  Medication Groups can be created from any medications in the central list and then exported
Alternate options
- Create a Project Variable Group that is a log of all subject medications
  - The variables can be customized
  - All of a subject's medications will be visible on one form
  - When exporting the data each medication will be in a separate column
- Create an Encounter Variable Group and assign to a non-fixed encounter
  - The variables can be customized
  - Each medication will be a separate non-fixed interval
  - A subject report can list all of a subject's medications on one report
  - When exporting the data each medication will be in a column
  - When it is expected that subjects will have numerous medications this option will result in many non-fixed intervals

Randomization

Information View information about the randomization configuration (randomization methods, blinding, stratification): Randomization
- What randomization method will be used?
- Who can randomize a subject (there is a separate randomization role)?
- Who can access / un-blind randomization (there is a separate view randomization assignment role)?
What are the practical mechanics involved in randomizing a subject?
How will subjects be screened (e.g. inclusion/exclusion criteria, run-in period design)?
Be sure there will be enough subjects to reasonably ensure the distribution across strata blocks are filled when using Stratification Factors
- In pilot studies the limited sample size typically limits the number of strata that can feasibly be used, maybe 1 or 2 variables at most.
  Info
  The number of strata are multiplicative across variables (e.g., 2 variables with 2 categories each = 4 strata groups)
Review if there are known confounding factors that need to be controlled
- The variables should be controlled in the randomization scheme (e.g., smoking status for a study on lung cancer)
- Consider the main dependent measure and whether any of the proposed stratification varaibles are 1) markedly related or 2) would differentially interact with the intervention

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Screening is used to determine if a subject meets the criteria to be included in the study
There can be multiple screening encounters
Screening encounters can also be used for visits that occur before Baseline/Time 0 but do not affect screening status
- The encounter that is set for Baseline determines the projected date of the follow-up encounters
- Baseline would be set for the visit that starts the timeline and prior visits would be set up as screening visits
All screening encounters must occur before Baseline/Time 0
Subjects who have not passed screening (they are still in-process or failed screening) cannot move to their Baseline or Follow-up encounters

Note
Screening cannot be removed from a project once subjects are screened to a project, Likewise, once subjects are enrolled in a project, screening cannot be added as a feature.

Subject Login

Used to allow subjects to log in and enter data
Subjects are set up with their own username and password from the Subject Overview page (by users with a Subject Administration role)
Subjects will only see the forms that are selected
See the Subject Data Entry page for more details

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This is not a common feature and complicates the project setup, verify this feature is desired before enabling
Versioning must be enabled to use Electronic Signatures
Unless you are testing the feature, do not turn it on until all the variable groups are created
With versioning enabled every change to a variable group requires a new version
Subjects that had data entered using a previous version can be upgraded to the new version of the variable group
Limitations
- You cannot select which version a subject will be upgraded to, they can only be upgraded to the latest version
- Correcting errors when there are a lot of subjects and/or encounters would require upgrading for each subject's encounter

Electronic Signatures

Allows a variable group to be electronically signed which locks the values and prevents changes
Versioning is required to enable Electronic Signatures
Separate roles are available for users to sign and/or un-sign a variable group
Variable groups are selected as to whether they can be electronically signed
Each variable group that is being signed or un-signed is checked and a password entered