Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Clinical Research > Data Management > Flashcards

Data Management Flashcards

1
Q

GIGO

A

Garbage In, Garbage Out: data quality can be made better with coding, but bad data cannot be saved.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

ICD

A

International Classification of Diseases

WHO. Standard Diagnosis Terminology

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

WHO ATC

A

WHO Anatomical, Therapeutic, Chemical

codiert nur die Wirkstoffe (Medikamententerminologie)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

WHO Drug / WHO DD(E)

A

Codes the drug name (ie: Aspirin Ratiopharm)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

MedDRA

A

Medical Dictionary for Regulatory Activities

Entwicklung und Pflege durch MSSO (Maintenance & Support Services Organisation)

Codiert Medizinische, gesundheitsbezogene und regulatorische konzepte für ALLE phasen der Entwicklung von arzneimitteln für den einsatz bei Menschen

Codes for events (Ereignissen) and not outcomes (ie: death)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

MSSO

A

Maintenance & Support Services Organisation

Develops and administers MedDRA

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

MedDRA: SOCs

A

System Organ Classes

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

MedDRA: PTs

A

Preferred Terms (2nd most specific)

Beschreiben ein einzelnes, abgrenzbares medizinisches Konzept (symptom, diagnosis, untersuchungsergebnis)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

MedDRA: LLTs

A

Lowest Level Terms

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

SmPC

A

Summary of Product Characteristics (label)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

RMP

A

Risk Management Plan

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

JMO

A

MedDRA nicht von MSSO in Japan abgedeckt. JMO administers Japanese Version.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Wie oft wird MedDRA weiterentwickelt (Updated?)

A

2 mal jährlich

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

CTCAE

A

Common Terminology Criteria for Adverse Events

developed by National Cancer Institute, mostly used in oncology studies to describe Klassifikation und Bericht von AEs, Schweregradeinteilungen die von MedDRA nicht abgedeckt werden.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

CTC

A

Common Toxicity Criteria

Klassifikation und Bericht von Chemotherapie-assoziierten Adverse Events bie Krebspatienten

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What should be done to increase the progress-curve of a study?

A
  1. relax ein/ausschluss kriterien
  2. increase enrollment, more marketing
  3. open more study centers
17
Q

Who is present at Blind Data Review meeting?

A

Project Leader (Project status)
Mediziner (SAEs, Coding)
Clinical Lead & CRA (protocol deviations)
DM Lead, DBP, CDA
Statistiker (Mock-Tables, protocol violations)

18
Q

ITT

A

Intent to Treat population (analysis)

In an ITT population, none of the patients are excluded and the patients are analyzed according to the randomization scheme. In other words, for the purposes of ITT analysis, everyone who is randomized in the trial is considered to be part of the trial regardless of whether he or she is dosed or completes the trial.
For example, if people who have a more refractory or serious problem tend to drop out of a study at a higher rate, even a completely ineffective treatment may appear to be providing benefits if one merely compares the condition before and after the treatment for only those who finish the study (ignoring those who were enrolled originally, but have since been excluded or dropped out).

Medical investigators often have difficulties in completing ITT analysis because of clinical trial issues like missing data or poor treatment protocol adherence.

19
Q

PPP

A

Per Protocol Population

This analysis can only be restricted to the participants who fulfill the protocol in the terms of the eligibility, interventions, and outcome assessment. This analysis is known as an “on-treatment” or “per protocol” analysis. Also, the per-protocol restricts the comparison of the treatments to the ideal patients, that is, those who adhered perfectly to the clinical trial instructions as stipulated in the protocol. This population is classically called the per-protocol population and the analysis is called the per-protocol-analysis. A per-protocol analysis envisages determining the biological effect of the new drug. However, by restricting the analysis to a selected patient population, it does not show the practical value of the new drug.

20
Q

Major protocol deviations

A
  • ICF not signed
  • Patients do not satisfy the inclusion and/or exclusion criteria,
  • Patient drop outs
  • A patient is randomized to Treatment A, but is treated with Treatment B,
  • Some patients are not compliant, that is, do not take their medication as instructed, and so on.
21
Q

Database Lock

A

Das Schließen einer Datenbank, nachdem alle Daten validiert wurden (Diskrepanzen addressiert und gelöst), sodass keine weiteren Änderungen vorgenommen werden können.

  1. Alle Patienten frozen und locked.
  2. Ein “Case Report Form summary” Report generated to confirm lock of all patients
22
Q

GCP for Data Management

A
  1. Quality control processes
  2. SOPs
  3. Dokumentation und Ablage
  4. Audit trails
  5. Training
  6. Validation
  7. Datenschutz
  8. Safeguard Blinding
  9. RTSM (Randomization & Trial Supply Management): maintain randomization codes and procedures for breaking codes
23
Q

Computer System Validation

A

dokumentierten Prozess, mit dem konsistent und reproduzierbar sichergestellt wird, dass ein Computer-System genau das tut, wofür es entwickelt wurde.

V-Modell

  • Zweck des systems vollständig, korrekt und effizient erfüllt wird.
  • Maßnahmen unternommen, das System in einem validierten Zustand zu halten.
24
Q

21 CFR Part 11

A

FDA kriterien für:

  • elektronische Daten und Signaturen als vertrauenswürdig, zuverlässig und gleichgestellt zu paper-docs.
  • bekräftigt die Anforderungen von GCP
25
Q

Clinical Data Manager, CDA tasks

A
  1. creating setup specifications for:
    - CRF
    - Data Validation Plan
  2. In-house data review
    - Cleaning / QUery management
    - reconciliation of SAEs
    - medical coding
26
Q

Clinical Database Manager

A
  • Database build
  • CRF umsetzen in DB system
  • validation programming
  • set-up acceptance testing environment
  • Listings erstellen
27
Q

Gemeinsame Tasks

Clinical DM and Clinical Database Manager

A
  • (computer system) validation
  • Quality management (documentation)
  • communication, soft skills, english
28
Q

ADaM

A

standard for data analysis (FDA)

29
Q

CDASH Library

A

Clinical Data Acquisition Standards Harmonization - defines standards for collection of data

30
Q

SDTM

A

Standard for clinical trial data submission (ie: EMA, FDA)

31
Q

CTCAE

A

Common Terminology Criteria for Adverse Events

  • National Cancer Institute
  • used in oncology studies
  • enthält schwergradeinteilungen die nicht von MedDRA abgedeckt werden.

Clinical Research (1 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions