Good Clinical Practice &Good Clinical Practice & Medical Record Documentation

Hanne Baekgaard Larsen&&

Terri Halverson

Objectives:Objectives:

Understand the history behind and define• Understand the history behind and define some key components of “Good Clinical Practice”Practice

Identify barriers to data extraction and• Identify barriers to data extraction and reporting

• Explore some possible approaches for making data abstraction more efficient and

2

making data abstraction more efficient and accurate

Good Clinical Practice & Medical Record Documentation

The history

Rigshospitalet, Copenhagen, DenmarkRigshospitalet, Copenhagen, DenmarkHanne Baekgaard Larsen RN MS h d t d tRN, MSc, ph.d. student

3

Pure Food and Drug Act of 1906

• The agricultural society and traditional medicine. • The Industrial Revolution.• The “Poison Squad” and the novel “The Jungle”.

4

1937 The Elixir Sulfanilamide Incident. • Sulfanilamide to treat

Streptococcal infections• Diethylene glycol =

tif d dlantifreeze = deadly poison (but pleasant taste)

• 107 people died

• Federal Food, Drug, and Cosmetic Act of 1938.

5

1941U.S. vs. Dotterweich.

• Buffalo Pharmacal Company charged with shipping adulterated and misbranded products e.g. p gdigitalis tablets

• Responsible individuals• Responsible individuals can be held personally accountable for the quality of the productsquality of the products manufactured by their company.

6

1960The Thalidomide Incident

• Used, in Europe, to treat sleep disorder and morning sickness in pregnant women.

• In Germany alone 5000 babies were born with birth defects.• 1962 Drug Amendment: safety requirements for testing on human

subjects, information on experimental drugs, adverse effects during clinical trials listing side effects as well as benefits

7

clinical trials, listing side effects as well as benefits.

1947The Nuremberg Code

• Voluntary consent of the subject • Results should be fruitful and not procurable by other

methods • Trial design should be based on the results of animal

experimentationexperimentation • Avoid unnecessary suffering and injury • If the researcher believes that death or disabling injury

may occur during the trial, the research is not legitimate and should not be doneand should not be done

• The degree of risk may not exceed the benefits of the experiment

• Every possible action must be taken to protect the subject from injury, disability or death Th i h ld b d d b i ifi ll• The experiment should be conducted by scientifically-qualified personnel

• The subject may terminate the trial at any stage • The investigator must be prepared to terminate the trial

at any stage

8

at any stage

1964 Helsinki Declaration

• The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principlesstatement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.material and data.

• The Declaration is intended to be read as a whole and each f it tit t hof its constituent paragraphs

should not be applied without consideration of all other relevant paragraphs

9

1961-1974Milgram Experiment

S i l h l• Social psychology experiments measured willingness to obey and

th it fi hauthority figure who instructed them to perform acts that

fli t d ith th iconflicted with their personal conscience.

• 65% (26 of 40) participants administered the experiment’s final

10

the experiment s final 450- volt shock.

1996I t ti l C f H i ti (ICH)International Conference on Harmonisation (ICH)

• Different guidelines in the U.S., Europe and Japan for clinical research => expensive drugs and long testing timetesting time.

• 1996: International guidelines for clinical trials incorporated into legislations (ICH-GCP)

11

legislations (ICH-GCP)

Definitions from ICH e gDefinitions from ICH e.g.• 1.52 Source Documents

O i i l d d d d ( h i l d• Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions

tifi d ft ifi ti b i t i i fi hcertified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).

12

Definitions from ICH e gDefinitions from ICH e.g.• 1.28 Informed Consent• A process by which a subject

voluntarily confirms his or her willingness to participate in a particular trial after havingparticular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent forminformed consent form.

13

The lessons from historyThe lessons from history

• Systematical gathering of data is necessary to gain new knowledge.

• To respect the individuals rights andindividuals rights and decisions when participating in clinical research

14

research.

Good Clinical Practice & Medical Record DocumentationMedical Record Documentation

Children’s Memorial HospitalChildren s Memorial HospitalTerri Halverson

RN BSN CPONRN, BSN, CPON

15

Good Clinical PracticeGood Clinical Practice

• International ethical & scientific quality standard q ydeveloped by the ICH

• Objectives:• Objectives:– economical use of

resourceseliminate unnecessary– eliminate unnecessary delays

– maintain quality, safety & efficacy safeguards

16

y g– protect public health.

Good Clinical PracticeGood Clinical Practice

Provides assurance that• The data and reported p

results are credible and accurate

• The rights, integrity and confidentiality of trial subjects are protected

17

Good Clinical PracticeGood Clinical PracticeProvides assurance that• The data and reported

results are credible and accurateaccurate = Quality data

• The rights, integrity and confidentiality of trial subjects are protected j p= Ethics

Q lit d t thi G d Cli i l P ti18

Quality data + ethics = Good Clinical Practice

Purpose of the Medical RecordPurpose of the Medical Record• Serve as a basis for planning patientServe as a basis for planning patient

care and for continuity of care

• Document patient's evaluation &Document patient s evaluation & treatment

• Document communication between• Document communication between health care professionals

• Assist in protecting the legal interest• Assist in protecting the legal interest of the patient, hospital & practitioner

P id d t f t d i i19

• Provide data for support decision analyses.

Medical record usesMedical record uses

• Clinical care

• Legal document

• Financial record

• Data– clinical research

20– decision analysis

“Legal” medical recordLegal medical record

R d l d t• Record released upon request for accrediting, regulatory, and reimbursement purposes

• Released to others if authorized.

I l d i fil d• Includes microfilm, scanned images, and the electronic record.

• Does not include aggregate or derived data, and administrative or business

21

records.

Medical Record DocumentationMedical Record Documentation

• Multi-disciplinary tool• Multi-disciplinary tool

• Held to various Standards, Regulations & requirements

• FormatFormat– Paper– Electronic

Hybrid– Hybrid

• Documentation not always

22

complete

Medical Record Data QualityMedical Record Data Quality

• Valid• Accurate• Accurate• Complete • Consistent• Timely• Accessible

• Confirm by audit

23

Problems extracting data from di l dmedical record

• Method:– Manually – Report

• Medical Record vs. ResearchResearch

• Clinical Definitions vs. Form definitions

• Lack of communication24

• Lack of communication

What has worked at Rigshospitalet& Child ’ M i l H i l& Children’s Memorial Hospital

• Source documentation from referring• Source documentation from referring physician

• “Orient” new physicians

• Keep physicians abreast of regulatory changes & updates

• Audits & Record reviews

• Error correction process

• Build specific information needs into documentation system (forms, drop-down menus, etc.)

25• Electronic Medical Record validation

• Communication

Business case for data qualityBusiness case for data quality

I ti t• Improve patient care

Public reporting /• Public reporting / transparency

• Opportunities for improvement

• Research: studies &

26

papers

ResourcesResources

• Guidance for Industry, Good Clinical Practice: http://www fda gov/cder/guidance/959fnl pdfhttp://www.fda.gov/cder/guidance/959fnl.pdf

• ICH Website: http://www.ich.org/cache/compo/276-254-p g p1.html

• Web Lecture Archive Project, University of j yMichigan: http://www.wlap.org/

27

Kara Hollis (Director, Health Information Management, CMH)( , g , )Lina Patel (Director, Hematology/Oncology/Transplantation, CMH)