Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801)

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Clinical Trials Glossary

Allocation

Arm type

Cross-over assignment

Factorial assignment

Intervention model

Masking

Parallel assignment

Primary purpose

Randomized allocation

Single group assignment

Study design

Study type

Last verified

Primary completion date

Recruitment status

Status

Study completion date

Study start date

Submitted date

Unknown

Active comparator arm

Experimental arm

Intervention/treatment

No intervention arm

Placebo

Placebo comparator arm

Sham comparator arm

Type of intervention

Accepts healthy volunteers

Age or age group

Baseline characteristics

Eligibility criteria

Enrollment

Exclusion criteria

Gender-based eligibility

Group/cohort

Inclusion criteria

Adverse event

All-cause mortality

Other adverse event

Outcome measure

Participant flow

Primary outcome measure

Secondary outcome measure

Serious adverse event

Study results

Early Phase 1 (formerly listed as Phase 0)

Phase

Phase 1

Phase 2

Phase 3

Phase 4

Phase Not Applicable

Certain agreements

Certification

Informed consent

Informed consent form (ICF)

Protocol

Quality control (QC) review

Statistical analysis plan (SAP)

Study documents

ClinicalTrials.gov identifier (NCT number)

NCT number

Registration

Study IDs

Study record

Study registry

Title

Title acronym

Collaborator

Data Monitoring Committee (DMC)

Funder type

Human subjects protection review board

Investigator

Principal investigator (PI)

Responsible party

Sponsor

Expanded access

Expanded access status

Expanded access type

FDAAA 801 Violations

U.S. Agency for Healthcare Research and Quality (AHRQ)

U.S. Food and Drug Administration (FDA)

Clinical study

Clinical trial

Interventional study (clinical trial)

Observational study

Observational study model

Patient registry

Canceled submission

Condition/disease

Extension request

Reporting group

Results database