Drug Accountability (Report)

Summary

Drug Accountability is required for regulatory purposes, generated by study managers and pharmacy teams for review and signoff by principal investigators. The report reviewed throughout various points of study conduct, typically at the end of each cohort, serving as a way to reference and review dosing activities and pharmacy operations. At the end of the trial, it is also reviewed by pharmacy teams and then provided to data management for further use.

Once generated, study managers review & optionally initial rows corresponding with certain dosing activities. When finished, they provide to the PI for final review and sign-off. The unblinded version of this report will be generated, reviewed, and provided to PI for signature. At the end of a study, pharmacy teams also generate and provide to DM teams for review.

Requirements

#	Requirement	User Story	Description	Jira Issue	Notes

#	Requirement	User Story	Description	Jira Issue	Notes
1	Blinding data for study managers	As a study manager, I need to see a blinded version of this report, because access to any reference to medication or reference numbers would not be appropriate.	Study managers must access a blinded version of this report; no medication or reference numbers.	FHSD-935
2	Unblinded data for pharmacy members	As a pharmacy team member, I need access to unblinded version of the report, because having access to reference numbers/medication numbers is appropriate for my use.	Pharmacy team must access an unblinded version, containing reference number and medication number.	FHSD-935	Report assumes a customer has configured a system role of ‘Pharmacy’ and applied to users intended to view unblinded version of the report.
3	Templated design with signature capability	As a PI, I need to be able to review and provide signoff on this report, because this indicates that I reviewed the report and is necessary per regulatory/sponsor request.	The report design must be based off a template providing an area for PI to apply a signature.	FHSD-935
4	Study identifiers	As a user, I need there to be applicable study identifiers available to me on this report, so that I can use this information to review the dosing activities.	The report should contain identifiers such as report name, date/time generated, Site ID, Study name, Protocol number, and Cohort	FHSD-935
5	Cohort specification	As a user, I need to be able to generate this report on a per cohort basis, because drug accountability review is done on a per cohort basis.	Users must be able to specify a cohort as input criteria to generate the report.	FHSD-935
6	Medication identifiers (unblinded)	As a user reviewing an unblinded version of the report, I need to be able to see specific details related to medication administration, because this information is a key element of drug accountability review.	Unblinded users must be be able to review Compound, content, regimen, administration details, administration date/time, and drug administrator.	FHSD-935	The medication identifiers will be reliant on the use of ALIAS configuration in form design.
7	Unscheduled dose forms	As a user, I need there to be unscheduled dose forms included in this report, because information on all dosing activities is required for drug accountability review.	The report must generate dose information for both scheduled activities (i.e. activities contained in the activity plan activated as part of a cohort assignment within a cohort) and unscheduled activities.	FHSD-2167

Design

This report requires that the Study Designer follow certain rules in designing Forms and is primarily driven by the use of Aliases at the Item Group and Item levels. The rules for this report are as follows:

A given Form may contain one-to-many drug administrations.
Items related to a given administration must be contained in one-to-many Item Groups defined by consistent Item Group Alias fields. The following Item Group Alias convention is expected:
- First Drug Administration:
  - Name = EXPOSURE
  - Context = 1
- Second Drug Administration:
  - Name = EXPOSURE
  - Context = 2
- Third Drug Administration:
  - Name = EXPOSURE
  - Context = 3
- And so on…
Reportable Items must follow the Item Alias convention described in the applicable sections of this specification document.
When more than one drug administration is contained in a given form each barcode-enforced Item must be named uniquely. -Note: It is suggested that Item naming be human-readable to facilitate barcode printing. For example: “Left Arm Dose”, “Right Arm Dose”, etc.
The drug administration Form must be the first reference activity in the containing Activity Plan.

Unscheduled Dose Forms

The report logic also considers unscheduled dose forms. Upon selecting a cohort as input, logic will look for unscheduled activities for each subject record contained in the cohort. If an unscheduled activity matches the Alias convention established for drug accountability reporting, the report will output that unscheduled activity.

As part of input, ‘Unscheduled’ is an option that searches for unscheduled activities across all subject and reports those activities which match the Alias convention established for drug accountability reporting.

Data Mapping

Study Name

Name of the study displayed to users when navigating ClinSpark. Defined in the Study > Configure component.

ClinSpark

Report

Protocol Name

Protocol name of the study reported during data exporting. Defined in the Study > Configure component.

ClinSpark

Report

Epoch

Epoch within which the cohort of interest is contained. Defined in the Study > Configure component.

ClinSpark

Report

Cohort

Cohort within which subjects of interest are contained. The activity plans in this cohort must contain a dose form with drug accountability information.

ClinSpark

Report

Randomization Number

Randomization (or “enrollment”) number is the subject number under which a subject has dosed or otherwise enrolled into the trial. These numbers are established within ‘Randomization’ style cohorts in the Study > Configure component.

ClinSpark

Report

Lead In Number

Lead-In number is the subject number under which a subject has participated in Day -1 of the trial. These numbers are established within ‘Lead-In’ style cohorts in the Study > Configure component.

ClinSpark

Report

Screening Number

Screening number is the subject number under which a subject has screened for a trial. These numbers are established within ‘Screening’ style cohorts in the Study > Configure component.

ClinSpark

Report

Volunteer ID

This is the unique identifier for each volunteer that follows the volunteer across studies.

ClinSpark

Report

Study Event

This is the study event associated with the reference activity (typically ‘dosing’) in the activity plan activated in the cohort of interest.

ClinSpark

Report

Compound

Compound fields are identified by use of the following Item Alias:

Name = EX_COMPOUND
Context = Drug accountability log

Note that Default Item Values may be established to pre-fill information that does not require a user response.

ClinSpark

Report

Content

Content fields are identified by use of the following Item Alias:

Name = EX_CONTENT
Context = Drug accountability log

Note that Default Item Values may be established to pre-fill information that does not require a user response.

ClinSpark

Report

Regimen

Regimen fields are identified by use of the following Item Alias:

Name = EX_REGIMEN
Context = Drug accountability log

Note that Default Item Values may be established to pre-fill information that does not require a user response.

ClinSpark

Report

Details

Details fields are identified by use of the following Item Alias:

Name = EX_DETAILS
Context = Drug accountability log

Note that Default Item Values may be established to pre-fill information that does not require a user response.

ClinSpark

Report

Medication Number

Medication fields are identified by use of the following Item Alias:

Name = EX_MEDICATION
Context = Drug accountability log

ClinSpark

Report

Administration Date/Time

Administration time fields are identified by use of the following Item Alias:

Name = EX_TIME
Context = Drug accountability log

Note that when more than one drug administration is contained in a given Form, the Item name for each administration time must be unique (i.e. “Left Arm Dose”, “Right Arm Dose”, etc). The Alias for each Item, however, may remain the same.

ClinSpark

Report

Administered By

This is the User associated with the most recent audit record for which a ‘Value’ is present for each date/time Item marked with the following Alias:

Name = EX_TIME
Context = Drug accountability log

ClinSpark

Report

Verified By

This field is intended to be completed on paper; there is not a corresponding ClinSpark field to capture this data.

ClinSpark

N/A