- 21 CFR Part 11
- ADR = Adverse Drug Reaction
- AE = Adverse Event Glossary
- AESI = Adverse Events of Special Interest
- BD = Business Development
- BDL = Business Development Lead
- Budget(s) / Bid
- CDA / NDA = Confidential Disclosure Agreement / Non-Disclosure Agreement
- Central IRB
- Centralized Monitoring
- Centralized Monitoring
- Clinical Operations / Operations
- Clinical Research
- Close out Period
- CM = Clinical Monitoring
- CO = Change Order
- Concomitant Medication
- Conduct = See the timelines in the CRO budget template for more details.
- Control Group
- COV = Close out Visit
- CRA = Clinical Research Associate (also called a monitor)
- CRC = Clinical Research Coordinator
- CRF = Case Report Form (or eCRF = electronic case report form)
- CRM = Customer Relationship Management
- CRO = Contract Research Organization
- CRO Services
- CSR = Clinical Study Report
- CTA = clinical trial assistant
- CTA = Clinical Trial Authorization
- CTL = Clinical Trial Coordinator
- CTMS = Clinical Trial Management System
- Data and Safety Monitoring Board (DSMB)
- Data Management Plan (DMP)
- DM = Data Management
- EDC = Electronic Data Capture system
- Electronic Clinical Outcome Assessment (eCOA)
- Electronic Source (eSource)
- EMR = Electronic Medical Record
- Enrollment
- Enrollment Period / Patient Recruitment Months / Period = Between FPI and LPI
- EOS
- ePRO (Electronic Patient-Reported Outcome)
- eTMF = electronic trial management files
- FIH = First in Human
- Food and Drug Administration (FDA)
- FPI = First Patient In
- FPS = First Patient Screened
- FSI / SIV = First Site Initiated / Site Initiation Visit
- FSWO = Full Scope Work Order
- FV or F/u Visit = Follow Up Visit
- Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
- HVs = Health Volunteers
- ICF = Informed Consent Form
- ID = Investigational device
- IP = Investigational Product
- IP = Investigation Product
- IRB = Investigational Review Board
- IRT (Interactive Response technology)
- IWRS = Interactive Web Response System
- Local IRB
- LPI = Last Patient In
- LPO = Last patient out
- Masking/Blinding
- MM = Medical Monitor or Medical Monitoring
- MSA = Master Services Agreement
- MV / IMV = Monitoring Visit or interim monitoring visit
- New Drug Application (NDA)
- Office for Human Research Protection (OHRP)
- Open-Label Trial
- Passthrough Fees
- PCM = Proposal and Contract Manager
- PD = Pharmacodynamics
- Pharmacokinetics (PK)
- PI = Principal Investigator
- PM = Project Management or Project Manager
- PoC Study = Proof of Concept Study
- Proposal
- Protocol
- Protocol Amendments
- Protocol Deviations (PD)
- Query
- Randomization
- Randomization and Trial Supply Management (RTSM)
- RC = Research Coordinator
- RECIST
- RFI = Request for Information
- RFP KOM = Request for Proposal Kick Off Meeting
- RFP = Request for Proposal
- SAD / MAD = Single Ascending Doses / Multiple Ascending Doses
- SAE = Serious Adverse Event
- Safety Monitoring Plan
- SC = Site Coordinator
- SDR = source data review
- Sentinel Subject / Group = One active- and one placebo-treated subject at the start of the study and at each dose increment.
- Site Compensation Budget / Investigator Fees
- SIV = Site Initiation Visit
- SIV = site initiation visit
- SoA = Schedule of Assessments
- SOC = Standard of Core
- SoE = Schedule of Events
- SOP = Standard Operating Procedure
- Source Data Verification (SDV)
- Sponsor, aka Client
- SQV = Site Qualification Visit
- Stratification
- SUA = Startup Agreement
- SubI = Subinvestigator
- Subjects
- SU = Start-up
- SUWO = Startup Work Order
- Vendors