Clinical Trial Assessment Windows: Recording a Late Visit Without Backdating
What to record when a trial visit falls outside its protocol window, how to classify the deviation, and when the SAP analysis window still counts the endpoint.
16 minBy
Category
Measurement & Operations
Outcome instruments, assessment schedules, and data quality.
PRO Recall Periods: When Daily and Weekly Answers Differ
Why daily diary averages and 7-day recall scores for the same PRO items diverge, what FDA guidance says about changing a recall period, and what to lock before the eCOA build.
16 minBy
Caregiver Diaries: Planning for a Change of Respondent
How clinical trial teams should specify caregiver eligibility, unique credentials, audit trails, and transition sensitivity analyses when diary respondents change.
23 minBy
COA Licensing: What to Confirm Before Building an eCOA Form
A pre-build confirmation guide for clinical trial teams: verifying electronic rights, scoring materials, validated translations, and protocol scope before an eCOA build starts.
21 minBy
Which Time and Record Count After an Offline eCOA Gap
How clinical trial teams handle offline eCOA entries: resolving wrong device clocks, duplicate records from replacement devices, and preserving audit trails under FDA, EMA, and ICH rules.
24 minBy
Remote eConsent: Documenting Identity Without Excluding Participants
How clinical trial teams write a proportionate remote eConsent identity ladder, file the identity note, and handle a missing-document fallback under 21 CFR 11.100, FDA and MHRA/HRA guidance, and the 2025 decentralised-elements recommendation.
20 minBy
eConsent Reconsent: Linking the New Version to Existing Participants
How clinical trial teams bind a newly approved eConsent version to already-enrolled participants without treating an upload as reconsent or overwriting original records.
22 minBy
REDCap eConsent: Versions, Signatures, and the Participant Copy
How clinical trial teams bind the current IRB-approved version, an attributable signature, and the participant copy in REDCap before opening enrollment.
21 minBy
MedConsumablesGuide: Reviewing Trial Kit Substitutions Before Collection
A clinical trial guide for reconciling protocol and lab-manual identity when offered substitute collection kits, separating transport compliance from endpoint assay comparability.
19 minBy
MedDeviceRepair: Assessing Endpoint Data After Analyzer Service
A structured guide for trial endpoint leads, laboratories, and biostatisticians on evaluating endpoint observations after an analyzer service event, separating equipment release from data review and SAP handling under 42 CFR 493, ICH E6(R3), and ICH E9(R1).
30 minBy
ClinRO Rater Training and Drift: Controls That Keep an Endpoint Interpretable
A methodological framework for clinical operations, biostatistics, and outcome-assessment teams to qualify, train, and monitor ClinRO raters—preventing endpoint drift without relying on start-up certification alone.
22 minBy
21 CFR Part 11 for eCOA: An Evidence Guide for Clinical Trial Teams
A structured guide for clinical operations, biostatistics, and data management teams to operationalize 21 CFR Part 11 compliance, audit trails, and UAT evidence for eCOA systems.
11 minBy
