Role: Study Designer
Before a study can be interacted with, it must be added in ClinSpark and a number of study-specific configuration actions must be performed.
Add the Study
Adding a new study begins by navigating to Administration > Studies and clicking the ‘Add’ button. This is the first action that occurs for every new study, after which a number of study-specific settings must be configured.
Configure Basics
First, establish the following basic configuration fields:
Name: ‘Nickname’ to be displayed via the Study Selector.
Protocol Name: Used for reporting of final deliverable datasets.
Description: Describes the type of study and related details.
Maintain Timing Offsets with DST: Defines how timing will be affected when daylight savings time is encountered. If Yes, time points relative to dosing will be maintained. If No, time of day will be maintained instead.
eSignature Strict: Defines whether one- or two-part authentication is required for data review signoffs during a login session. If checked, Username and Password are required for every signoff during a login session. If unchecked, Username and Password are required for the first signoff during a login session and Password-only is required for subsequent signoffs during that same login session.
MedDRA Dictionary: Establishes the dictionary to be used for coding of medical conditions for the study.
WHO Drug Dictionary: Establishes the dictionary to be used for coding of medications for the study.
Sites: Establishes the site(s) at which the trial will be performed.
Epoch Names: Establishes the ‘stages’ of the trial, typically delineated by potential stopping points at which a subject may not necessarily progress forward.
Set Sample Packaging Rules
The following sample processing rules dictate how samples may be packaged at the end of sample processing workflows:
Enforce Container Path: If checked, only samples which share the same sample processing path may be packaged together. Meaning that ‘Analyte A’ samples may not be mixed with ‘Analyte B’ samples. If unchecked, samples may be packaged together regardless of sample path. Meaning that ‘Analyte A’ samples may be mixed with ‘Analyte B’ samples.
Enforce Container Transfers: If checked, only like aliquots may be packaged together. Meaning that ‘Primary Aliquot’ samples may not be mixed with ‘Backup Aliquot’ samples. If unchecked, different aliquots may be packaged together. Meaning that ‘Primary Aliquot’ samples may be mixed with ‘Backup Aliquot’ samples.
Configure Advanced ECG Review
If CalECG is intended to be leveraged to support advanced ECG review, display and review strategies may be established on a per-study basis to provide sensible waveform defaults during the review process. The following defaults may be configured to support interaction with ECG waveforms:
ECG Review Strategy: Default review strategy per ECG measurement protocol (Three Consecutive Beats, Representative Beat, Super Imposed).
ECG Review Lead: Lead to be measured (I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6).
ECG Display Strategy: Default display strategy per ECG measurement protocol (Three Consecutive Beats, Representative Beat, Super Imposed).
ECG Display Lead: Default lead to be displayed (I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6). If no lead is specified, all leads will be displayed.
ECG Compute Annotations: If checked, caliper positions will attempt to default upon measuring the ECG.