Clinical Data Entry

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Questions and Answers

Match the following terms with their corresponding definitions in the context of clinical trials:

Clinical Data Integration System (Clinstore) = System for integrating clinical data Participant Diary Data = Data collected from participants during a study Electronic Data Capture (EDC) = System for capturing clinical trial data electronically External Data Provider = Organization providing external data for a clinical trial

Match the following systems with their corresponding functions in clinical trials:

IRT (Interactive Response Technology) = System for managing study participant interactions EDOO = System for managing Phase I studies CDMS (Clinical Data Management System) = System for managing clinical trial data Genzyme-Rave = System for clinical trial data management (retired)

Match the following terms with their corresponding concepts in clinical trials:

Data Entry Conventions = Rules for entering data into a CRF Screening Failures = Failed screenings of study participants Database Lock = Finalizing a study database Direct Data Integration = Method of integrating data directly into a CDMS

Match the following terms with their corresponding concepts in clinical trials:

CRFs = Case Report Forms used to collect study data Paper Forms = Paper-based forms used to collect study data EDL = Method of loading data electronically for adjudication FTS = Format for transmitting study data Signup and view all the answers

Match the following systems with their corresponding functions in clinical trials:

Oracle Clinical = System for clinical trial data management (retired) Genzyme Clintrial = System for clinical trial data management (retired) EDOO = System for managing Phase I studies Clinstore = System for integrating clinical data Signup and view all the answers

Match the following terms with their corresponding concepts in clinical trials:

Study Operation Manual = Guideline for conducting a clinical trial (removed) Patient Diary Data = Data collected from participants during a study (renamed) Clinical Data Management Integration System = System for integrating clinical data (renamed) Data Management = Process of managing clinical trial data Signup and view all the answers

Match the following terms with their corresponding concepts in clinical trials:

External Data Provider = Organization providing external data for a clinical trial IRT = System for managing study participant interactions Electronic Data Capture (EDC) = System for capturing clinical trial data electronically Direct Data Integration = Method of integrating data directly into a CDMS Signup and view all the answers

Match the following terms with their corresponding concepts in clinical trials:

Study Participant = Individual participating in a clinical trial CRFs = Case Report Forms used to collect study data Paper CRF = Paper-based CRF used to collect study data Data Entry = Process of entering data into a CRF Signup and view all the answers

Match the following terms with their corresponding concepts in clinical trials:

Screening Phase = Phase of a clinical trial where participants are selected Data Integration = Process of integrating clinical trial data Clinical Data Management = Process of managing clinical trial data External Data Loading = Method of loading external data into a CDMS Signup and view all the answers

Match the following terms with their corresponding concepts in clinical trials:

Quality Control = Process of ensuring data quality in a clinical trial Data Management = Process of managing clinical trial data Clinical Data Integration = Process of integrating clinical trial data External Data Provider = Organization providing external data for a clinical trial Signup and view all the answers

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