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Medsurv

Glossary

Technical term keywording
and encyclopedia of our services

MedSurv-Glossary

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A

AE

Adverse event
An incident that occurs in a temporal context with the administration of a drug. This can be e.g. changes in laboratory values, new occurrence of symptoms or diseases. The incident does not have to be causally related to the drug administration.

Audit Trail

Tracking of all data changes according to regulatory requirements

B

C

CDISC

The Clinical Data Interchange Standards Consortium

is a standards developing organization (SDO) dealing with medical research data. CDISC is a standard accepted by the FDA in the USA for the submission of clinical data for drug approval.

Clinical studies

A clinical trial is in evidence-based medicine and clinical research or survey and is a prerequisite for regulatory approval of drugs and pharmaceuticals.

CRF

The Case Report Form
is a paper questionnaire specifically used in clinical trial research to capture data from each participating subject in anonymized form.

CRO

A contract research organization
is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.

CTM

The Clinical Trial Management
is a reporting tool for access to various predefined overviews and graphics.

D

Data capture

Data capture refers to all methods of recording, measurements and counts, including time stamps for measurable or countable data and groups of related data.

Data Management

Additional eCRF validation process according to DVP

Document Upload

Upload of study related documents with and without subject assignment.

DVP

Data validation plan
is a list of all parameters and planned tests on the data set of a study.

E

eCRF

Electronic Case Report Form
is the digital version of a CRF. Virtual data entry or result sheet, also called EDC (Electronic Data Capture) sheet.

EDC System

Electronic Data Capture
complies with the definition eCRF.

eDiary/ ePRO

Electronic Diary, electronic Patient Reported Outcomes
is a digital diary in which patients can independently record their data within a study.

eQuestionnaire

Electronic questionnaires
are, for example, product questionnaires as part of a PMCF study.

EU GxP Annex 11

Guidelines to the EC GMP Guideline

F

FDA

United States Food and Drug Administration
(https://www.fda.gov)

Full Service

We can offer a full service with reliable and internationally active partners, such as CROs, data managers, statisticians, biometrists, etc.

G

GAMP5

Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture
This guide, first published in 1994, has become the standard set of rules for the validation of computerized systems in the pharmaceutical industry. The GAMP regulations are not legally binding and are used in different ways for the validation of computerized systems.

GCP

Good Clinical Practice
This practice is derived from the Declaration of Helsinki, among other things, and refers to internationally recognized rules for conducting clinical trials for the benefit of patients, based on ethical and scientific criteria.

H

I

ICH

International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use

Guideline for the worldwide unification of the techniques and standards in clinical research.

ISO 9001

ISO 9001
describes the requirements for the management system of an organization to meet a certain standard in the implementation of quality management.

J

K

L

M

MedSurv-Portal

The MedSurv-Portal is an Online EDC, eCRF system for data capture in clinical studies.

Monitoring

Monitoring is a data approval of study data. With the help of a modern EDC system, this test can be carried out online.

N

NIS

Non-interventional studies
are studies in which no study-related intervention is made on study participants.

O

P

Patient registry

A patient register is used to record patients and their disease progression in a collection.

PMCF

Post-Market Clinical Follow-Up
This is a study that determines whether the safety and efficacy of a medical device is ensured after market launch.

Product Questionnaire

Electronical questionnaires, such as a product questionnaire as part of a PMCF study.

Q

Query Management

Query Management allows direct communication in the EDC system via questions and answers.

R

Randomization

A procedure in which patients are assigned to different groups using a random mechanism.

S

SAE

Serious adverse event
A serious incident occurring in a patient or subject during a clinical trial with drugs or medical devices.

T

U

US FDA 21 CFR Part 11

US FDA 21 CFR Part 11
describes the US Food and Drug Administration (FDA) regulations for electronic records and electronic signatures. Although defined in the USA, it is considered an international standard.

V

W

X

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