MLS Chapter Notes -Forensic Pathology, Anatomical Pathology, Cytogenetics

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ruthzyles

9 Apr 2023

School

Saint Louis University - Baguio City

Department

Health Sciences

Course

MLS

Professor

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Document Summary

2007-0027 (revised rules and regulations governing the licensure and regulation of. Clinical laboratories in the philippines: clinical laboratory. A facility where tests are done on specimens from the human body to obtain information about the health status of a patients for the prevention, diagnosis, and treatment of diseases. Other functions are to provide consultative advisory services covering all aspects of laboratory investigation including the interpretation of results and advice on further appropriate investigation. Also include areas that are involved in the collection, handling, and or preparation of specimens and those that act as mailing or distribution centers: routine testing. The basic, commonly requested tests in the laboratory, the results of which are not required to be released immediately upon completion. It shall follow the usual procedures and system in the laboratory: stat tests. Tests done on urgent cases, the result of which shall be released immediately, within one (1) hour after the procedure: point of care testing (poct)

Related Questions

Match the following terms/acronyms to their definition below: clinical event committee (CEC), core laboratory, contract research organization (CRO), data safety and monitoring board (DSMB), endpoints, inclusion criteria, power.

Characteristics or indications that subjects must have in order to participate in the clinical trial

DSMB

The probability of detecting a meaningful difference, or effect, if one were to occur

CRO

Prospectively identified and quantifiable parameters that a study is designed to meet

Inclusion criteria

An independent organization that provides management services for clinical trials

CEC

An independent body that periodically reviews the results of clinical trials in the US to ensure that patients are not being inadvertently harmed by the study

Endpoints

An independent body that adjudicates clinical events and reports the results to both the trial investigators and the study sponsor

Power

An independent body that analyzes data or images from a clinical trial to make specialized quantitative measurements required by the trial protocol

Core laboratory

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When it comes to using clinical data collected outside of the US to support a US regulatory submission, it’s important to understand that:

a. FDA expects clinical trial design and conduct to conform with relevant local regulations and applicable Good Clinical Practices

b. FDA looks critically at data obtained from foreign studies in terms of its applicability to the US patient population

c. FDA reserves the right to audit foreign clinical sites to confirm whether or not the data is valid for the purposes of obtaining an approval to market a device in the U.S

d. All of the above

rafi_mokdad

Match the following study types to their definition below: case control study, randomized controlled trial, registry, Investigational Device Exemptions (IDE)

Prospectively comparing the outcomes of patients randomly assigned to be treated with a new device or procedure relative to a control group that may receive no treatment or standard treatment

Case control study

Monitoring outcomes through a collection of cases performed in a real world, which may be accumulated either prospectively or retrospectively after a number of cases have been performed

Registry

Retrospectively comparing the outcomes of a group of patients treated with a new device or procedure to a matched group receiving no treatment or a standard treatment

Investigational Device Exemptions (IDE)

Allows a device to be used in a clinical study in order to collect safety and effectiveness data.

Randomized controlled trial

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MLS Chapter Notes -Forensic Pathology, Anatomical Pathology, Cytogenetics

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