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These data are usually later entered in the case report form.
Case report forms are available from the state or local health jurisdiction.
Data collection Data were collected using standard case report forms.
Case report forms contain data obtained during the patient's participation in the clinical trial.
Case report forms are manually filled at site and mailed to the company for which trial is being performed.
The composite end-point was also calculated using the site investigator determination of MI from case report forms.
The Case Report Form is the tool used by the sponsor of the clinical trial to collect data from each participating site.
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research.
He said that Dr. Oswald, in his shuffling through case report forms, "has a habit of taking trivial events" and exaggerating their importance.
The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS.
"We don't have any good method to determine whether what is on the case report forms is identical to what is on the tabular summaries."
There will be two Case Report Forms (CRF).
The Case Report Form (CRF) is the data collection tool for the clinical trial and can be paper or electronic.
The purpose of the case report form (CRF) is to collect relevant data in accordance with the protocol and in compliance with regulatory requirements.
The clinical data is to be entered online at 4 time points; amounting to four Case Report Forms (CRFs).
Case Report Form (CRF)
Standard Operating Procedure - Develop and Manage a Case Report Form links to CRF information (PDF)
The ICH guidelines on Good clinical practice (GCP) use the term 'Case report form' or 'CRF' to refer to these systems 1 .
Personal identifiers and linkage codes are kept only at the clinical center where the study subject was enrolled and will not be recorded on case report forms or stored in the study electronic database.
Folders included the case report form and ancillary data forms, discharge summaries, cardiac enzyme results, ECGs, and a data worksheet that summarised clinical events, procedures, and cardiac enzyme information.
In a traditional medical research study, the Principal Investigator, Research Coordinator, or other study staff conducts an interview with the research subject and records the information on a paper or electronic Case Report Form.
A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with clinical research investigators.
Medical Records Study coordinators review the medical records of the initial evaluation of stroke cases to complete case report forms for documenting eligibility and baseline data and to construct the abstracted medical record used for stroke subtyping.
A discrepancy between case report forms and company analyses would not ordinarily be apparent to the F.D.A., Dr. Lisook said, partly because the agency does not even receive most case report forms.
Information concerning dates of maternal HIV tests, receipt of prenatal care, maternal and neonatal receipt of antiretroviral drugs, mode of delivery, and breastfeeding is collected on the pediatric HIV/AIDS case report form (115).