RESEARCH CLINICAL SLWK PRACT I
RESEARCH CLINICAL SLWK PRACT I SLWK 706
Virginia Commonwealth University
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This 207 page Class Notes was uploaded by Miss Heaven Larson on Wednesday October 28, 2015. The Class Notes belongs to SLWK 706 at Virginia Commonwealth University taught by Staff in Fall. Since its upload, it has received 17 views. For similar materials see /class/230610/slwk-706-virginia-commonwealth-university in Social Work at Virginia Commonwealth University.
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Date Created: 10/28/15
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Ethical Issues In Research An opening case study Research costs and benefits Major ethical issues Stress and psychological harm Deception Informed consent Debriefing Alternatives to deception Privacy and confidentiality Special populations Formulation of ethical principles Research with human participants Ethics and animal research Fraud 9162005 Taryn n M V tten thD MSW FGSA Milgram s Obedience Experiment 1 I Stanley Milgram 1960 s wanted to study obedience to an authority gure I Placed an ad in local newspaper to recruit men to participate in a scientific study of memory and learning I Would pay 450hr I Clients came to Yale lab and met two people White coat scientist Middle aged man named Mr Wallace a confederate 7 7 participant in the study 39 9162005 Tany n39n M V tteh PhD MSWgtFG A 3 Milgram s Obedience Experiment 2 I Scientist explains study is about effects of punishment on learning I One person would be teacher and would administer punishment other would be the learner I Participants would draw paper slips to see which role they would play I Study rigged so Mr Wallace was always the learner I Scientist attaches electrodes to head of Mr Wallace I Shock machine has graduated voltages that teacher is to administer Voltages labeled mild moderate and severe danger followed by red X s I Mr Wallace instructed to learn a seriesof word pairs and given test to see if he could identify Which 39 39 words went together 9162005 Tany n39an V tten Pm MSWLFG A 4 Milgram s Obedience Experiment 3 I Scientist explains study is about effects of punishment on learning I One person would be teacher and would administer punishment other would be the learner I Participants would draw paper slips to see which role they would play I Study rigged so Mr Wallace was always the learner I Scientist attaches electrodes to head of Mr Wallace I Shock machine has graduated voltages that teacher is to administer Voltages labeled mild moderate and severe danger followed by red X s I Mr Wallace instructed to learn a seriesof word pairs and given test to see if he could identify Which 39 39 words went together 9162005 Tany n39an V tten Pm MSWLFG A 52 Milgram s Obedience Experiment 4 l Teacher was told to administer graduated shocks as Mr Wallace made mistakes I Teacher unaware no shocks actually occurred I As shocks increased Mr Wallace made more mistakes and increased yelling when shocked I If teacher wanted to quit scientist urged teacher to continue I Milgram really interested in learning whether or not participants would obey experimenter to administer increasing shocks to Mr Wallace 9162005 Tany n39an V tten PhD MsvEG A 6t Milgram s Obedience Experiment 5 I What happened I 65 of participants continued to give shocks to 450 volts lWhat are some of the issues here Participant psychoemotional stress Deception Informed consent Debriefing 9162005 Tany n39nnM V tten PhD MSW FGSA 7quot Other Problematic Studies I The thalidomide tragedy 1960 s I Untreated syphilis in the negro the Tuskegee Study 1930 s I Human radiation experiments 1944 1974 9162005 Taryn n M V tten thD MSW FGSA Principle of Beneficence l Requires investigators to design studies that will produce valid and generalizable knowledge and to ensure that the benefits of the research are proportionate to the risks assumed by the participants 9162005 Tany n n M V tteh PhD MSW FGSA Principle of Justice l Requires that the benefits and burdens of research be distributed fairly Research participants assume some risk in order to benefit society Therefore no single group especially not disadvantaged vulnerable or minority groups should be asked to bear a disproportionate share of the study risk 9162005 Tany n39n M V tteh P hD MSWgtFG A Good Research Prac rice 9162005 Rees et Traim ig Please ask questions o Active participation is a must Tarynn M V tten PhD MSW FGSA Why are we here w wwl 9162005 Taryn n M V tteh thD MSW FGSA 131 Significance of Good Research Practice GRP Provides public assurance that Rights Well being and Con dentiality of trial subjects protected Trial data are credible 9162005 Tarynn M V tten PhD MSW FGSA History of Research We ve come a long way if 9162005 Tarynn M V tten PhD MSW FGSA Nuremberg Code oz Informed consent obtained without coercion 391 Based upon prior animal experimentation 393 Results should justify the eXperiment rt Medical research only by qualified scientists ot Physicamenta suffering and injury avoided 6N0 expectation of death or disabling 9162005 Taryn n iM V tten PhD new FGSA 1L6 Research Hall of Shame Elixir of Sulfanilamide Tragedy 1937 I Dissolved in diethylene glycol I 107 deaths I NO requirement to TEST the elixir for safety prior to human consumption I Result 1938 Federal Food Drug And Cosmetic Act mandated premarket review new drugs for safety and labeling of experimental drugs Willowbrook State School 1956 Purpose Study etiology of infectious hepatitis and test effects of gamma globulin in preventing disease Fed subjects extracts of infected stool 9162005 Tany n39n M V tten P hD MSWgtFG A 9162005 Jewish Chronic Disease Hospital 1963 Injection of live cancer cells into 22 patients No written consent Some verbally informed involved in experiment Never told being given live cancer Guilty of fraud deceit unprofessional conduct Taryn n M V tten P hD MSW FGsA The Tuskegee Syphilis Study I 1932 to 1972 l 399 African American Males were denied treatment for syphilis I Study conducted by Public Health Service 9162005 Tany n39an V tten PhD MSWLFGSA 3921 Obedience to Authority 1963 I Subjects reported extreme I psychological stress Q I No informed consent I Deception 39 h 7 H f a i iii2 35quot Wendiinst ii The Declaration of Helsinki 39 Produced 1961 adapted 1964 i Informed consent ethical research 39 Basis for FDA policy 9162005 Tarynn M V tten PhD MSW FGSA From President Clinton I quotAlthough these regulations Protection of Human Subjects Code of Federal Regulations Title 45 Part 46 provide the framework for protecting human subjects in research we must exercise constant care and ensure that these regulations are strictly enforced by departments and agencies Therefore I direct each department and agency of Government to review present practices to assure compliance with the Federal Policy forthe Protection of Human Subjects and to cease immediater sponsoring or conducting any experiments involving humans that do not fully comply With the Federal Policyquot Bi Clinton 1994 I The people who ran the study at Tuskegee diminished the stature of man by abandoning the most basic ethical precepts A They forgot their pledge to heal and repair They had the poWer to heal the surVivors and all the others and they did not Today all we can do is apologizequot Bif Clinton 199739 9162005 Taryh nVM vvtten Pho MSWEG A 24 National Research Act of 1974 Created National commission for the protection of Human Subjects of Biomedical and Behavioral research Charge was to Identify basic ethical principles that should underlie conduct of biomedical and behavioral research involving human subjects 9162005 Taryn n M V tten PhD MSW FGSA More specifically consider Boundaries between research and practice Role of assessment of riskbene t Selection of subjects Nature and de nition of informed consent Result was 1976 Belmont report 9162005 Tarynn M V tten PhD MSW FGSA Good Research Practice Why Have this Training 9162005 Tarynn M V tten PhD MSW FGSA 27 Wisdom and Knowledge in the Treatment of Addiction After de ning the Wisdom Tradition and and Knowledge ask participants to generate ideas of knowledge related to the following themes Write these on an easel and select a pair to draw comparisong Origins of humans Brainstorm for examples fromof knowledge from the Wisdom tradition eg religion Brainstorm for examples from Modern Knowledge tradition eg evolution 9162005 Tany n39an V tten P hD MsvEe A 2398 Science and the CTN Goal of CTN is to develop bidirectional relationship between CTPs 17 f and the research community 9162005 Tany nththgjriPHDuMsiwgfegi 7 n 7quot 4 gs Ways of knowing Method of tenacity repetition Method of authority because I said so A priori method common sense Scientific method hypothesis testing 9162005 Taryh nFM V tten PhD mew FGSA 30 Scientific Method Individuals come to understand what is true by testing a set of assumptions using systematic observations or measurements 9162005 Taryn n M V tten P hD MSW FGSA 31 Ways of knowing in Substance Abuse Treatment The Wisdom Tradition Looking to the past to the wisdom and insights of previous generations and those who went before to solve addiction problems Examples Modern Knowledge seeks to develop and test hypotheses so that new knowledge is gained Examples 9162005 Taryn n M V tten thD MSW FGSA Wisdom and Knowledge Cures for health problems egheadache Origins of mental illness 0 Brainstorm for examples of remedies from the Wisdom tradition o Brainstorm for examples from Modern Knowledge tradition 9162005 Taryn39n iM V tten PhD MSW FGSA 33 A question or problem anses Disseminate findings 41 Interpret f 1quot Refine intoa results hypothesis gt 4 quot VVSelect sampl from the Analyze r I V Implement I a pulation observations procedures to measurements a impact problem f L Systematic observations 9162005 4 measurements Tr 34 Research 1 O1 Phases of Research Phase I First studies in humans with new drug Normal healthy volunteers Phase II increased number of volunteers Looks at therapeutic effect and to determine optimal dose range and frequency Phase III Large multicenter comparative studies Needed to show safety and efficacy Phase IV Postmarketing Studies to further evaluate safety of FDA approved drug 9162005 Taryn n M V tten PhD Msvv FesA 36 Data collection IWhat do you want to measure I How should you measure it 9162005 Tany n39an V tten Pm MSWEG A Types of Measures I Subjective vs objective ubjective ask questions about the participants perspective must be interpreted with caution no way to confirm Objective collect data through direct observations or measurement Provide easily verifiable data 9162005 Taty n n M V tten PhD MSW FGSA 138 Types of Measures cont Retrospective vs prospective etrospective assesses past information ros ective assesses information in an ongoing manner 9162005 Tarynn M V tten PhD MSW FGSA Reliability How accurately something is measured Estimate kind of short Crude 12 hands Ruler 6 foot 2 inches Laser 16448795050 cm 9162005 Tarynn M V tten PhD MSW FGSA Validity I How well the instrument measures what it is supposed to measure Measures of attractiveness lHeight lWeight lBank account balance 9162005 Taryn39n39lM the n PhD MSWMEC A 39 3941 Generalizability Conclusion Foss therapy is superior to methadone in promothg drug abethence 9162005 Tarynn M V tten PhD MSW FGSA Group Exercise e What are some activities that you do a couple of times a week How might we measure that 9162005 9162005 Research Language PatientClient is referred to as Human Subject V01unteer Participant Tarynn M V tten PhD MSW FGSA Inclusion Criteria Criteria if ful lled will make patient eligible to participate in a research study 9162005 Tarynn M V tten PhD MSW FGSA Inclusion Criteria In CTNMET they are gtSeeking treatment for current substance use problem gtMales and Females at least 18 years of age gtCurrent stable living arrangement gtAble speak read and write English gtWilling to be randomized into treatment and be contacted for followup interviews gtLikely to be in the area for the next 4 month s gtAble to understand and give informed consent 9162005 Taryn n M V tteh thD MSW FGSA 46f Inclusion Criteria In CTNBUP 002 they are gtMales and Females at least 15 years of age gtDSMIV diagnosis of Opiate Dependence gtAble to understand study gtAble to provide written informed consent gtlf female either unable to bear children or willi ng to use an acceptable method of birth control 9162005 Taryn n M V tteh thD MSW FGSA 47quot 9162005 Exclusion Criteria List of criteria any would exclude patient from participating Tarynn M V tten PhD MSW FGSA Exclusion Criteria In CTNMET they are gtSeeking detoxification only methadone maintenance or inpatient treatment for substance use problem gtSeems to have dementia or other irreversible organic brain syndrome gtParticipated in MET protocol previously gtSignificant suicidalhomicidal risk gtFacing incarceration fora period of greater than three weeks gtSpouseISO currently enrolled in MET protocol 9162005 Taryn n M V tten PhD MSW FGSA Exclusion Criteria In CTNBup 002 they are gtHaving a medical condition that would make participation medically hazardous gtClinically significant ECG abnormalities gtAlergy or sensitivity to Buprenorphine Naloxone or Clonidine gtHaving an acute severe psychiatric disorder gtAn immediate risk of suicide gtDependency upon alcohol b enzodiazap ine s r other depressants or stimulants 9162005 Taryn n M V tteh thD MSW FGSA E50 Exclusion Criteria Cont gtHaving a medical condition that requires immediate attention gtHave participated in another study in past 30 days gtTaking medication which may interact adversely with clonidine gtHave had methadone or LAAM maintenance or detoxification in past 30 days gtHave pending legal actions which may interfere with their ability to remain in study for the duration gtAny other situation which may interfere with their ability to remain in study for the duration 9162005 Taryn n M V tten PhD MSW FosA 5 1 Random assignment Predetermined system by which patients are assigned to treatment group 9162005 Taryn n iM V tten P hD MSW FG 9162005 Blinding Procedure for assuring nonbias in clinical trials Tany n39an V tte ri PhD MSW EG A Good Research Practice Human subjects protection 9162005 Tarynn M V tten PhD MSW FGSA 54 The Belmont Report 0 3 Basic Principles for Protection of Human Subjects Respect Beneficence Justice 9162005 Taryn n M V tten thD MSW FGSA 9162005 Respect Ivoluntary informed consent Iprivacy lprotections for vulnerable populations Tarynn M V tten PhD MSW FGSA MaMerable Populatibns 1 31M 31 39 ii Pregnant Women 1 Handicaps 1 Mental Disabilities 11 Econor lclEducational Disadvantages J Femses and Fetal Material mm Trynn Ii When PM MSW PGSA Bene cence Persons treated in an ethical manner o Protecting them from harm i Helping to secure their well being 9162005 Taryn n M V tten PhD MSW FGSA Jus ce Who receives the benefits and bears the burden of research o Equals to be treated equally Fairness 39in distribution 9162005 Taryn39n iM vutten PhD MSWEG A Justice Applied to Research 0 Selection of subjects 0 New therapies not only provided to those who can afford them 0 Not unduly involve persons from groups unlikely to benefit 9162005 Taryn39n iM V tten PhD MsvviesA foo 9162005 Regulatory Tarynn M V tterquotl PhD MSW FGSA Roles And Responsibilities Tarynn M V tten PhD MSW FGSA mamas TmounampquotResponsibility 9 94 mm WW MM 63 Protecting Participants mplementing Study Reporting Accurately Investigator Obligations Conducts a clinical investigation 0 Responsible for gtAI procedures conducted gtAI data cllected 0 May delegate work but retain responsibility 9162005 Taryn n M V tteh P hD MSW FGSA f6439 Responsibilities Clinic Staff 1 Know the protocol J Consult get supervision o en l Adhere to protocol TI Communicate notes calls 9162005 Research Staff 1 Know the protocol J Consult get supervision o en 1 Adhere to protocol 1 Communicate notes calls J Maintain Study Binder Tarynn M V tten PhD MSW FGSA 9162005 Good Clinical Practice Human Subjects Protection Tarynn M V tten PhD MSW FGSA Human Subject Protection I Informed consent I Institutional Review Boards I Confidentiality I Certificate of confidentiality I InclusionExclusion criteria I Safety Monitoring I Office for Human Research Protection OHRP I Investigator and study personnel 9162005 Taryn n M V tten thD MSW FGSA 9162005 General Rule for Human Subject Protection Any element of research r Yes Undergo review Tarynn M V tten PhD MSW FGSA a I n What s an Irb anyway 9162005 Tany n39an vmnen P hD MSWFG A Institutional Review Board Definition an independent body of medical scientific and nonscientific members designated by an institution to review and approve biomedical research involving human subjects FD CH 15997 9162005 Taryn n M V tten P hD MSW FGSA 70 Institutional Review 9162005 Board 1 Safety 2 Integrity 3 Human rights 4 Public reassurance 5 Scientific content Taryn n M V tten P hD MSW FGsA Who is on the IRB Committee J 35 people J Differing professions At least 1 from science 1 from non science area Majority to make a quorum J Special populations expert I Cannot vote on own research 9162005 Tarynn M V tten PhD MSW FGSA 72 The IRB has the Authority to 1 Approve 1 Disapprove 39l Require modifications 9162005 Tarynn M V tten PhD MSW FGSA When Multiple IRBs Options for Joint review Separate reviews Accept review from other qualified IRB 9162005 Tarynn M V tten PhD MSW FGSA Exemption from Review 1 Anonymous data obtained from educational tests 1 Residual biological material J DOES NOT apply to research involving deception or vulnerable populations 9162005 Tarynn M V tten PhD MSW FGSA Criteria for Expedited Review 1 Minimal risk 1 Minor changes of approved research J Cannot be used for disapproval 1 Needs one or more members 9162005 Tarynn M V tten PhD MSW FGSA 76 IRB Operating Procedures I Provide reports of findings and requested actions to investigators after initial amp continuing reviews I Annual review of studies to determine if level of risk has changed I Approving changes to research prior to implementation I Prior approval of changes in protocol except to eliminate hazard 9162005 Taryh nVM V tten PhD Msvv FGSA 77quot Reporting Requirements I Investigators must make an immediate report to IRB and possibly other institutions if they experience Unanticipated problems involving risks Noncompliance with IRB requirements or federal regulations Suspension of IRB approval 9162005 Tany n n M V tten P hD MSW FGSA An IRB may Suspend Research J 1 Not conducted in accordance with IRB requirements 391 Associated with unexpected harm 9162005 Tarynn M V tten PhD MSW FGSA Criteria for Approval I Risks minimized I Reasonable riskbenefit ratio I Equitable selection of subjects I Informed consent obtained appropriately I Informed consent adequately documented I Monitor data to insure safety I Protect confidentiality I No coercion 9162005 Tanyh n iM V tten P hD MSW FGSA Valid Informed Consent Informed Understood Voluntary 9162005 Taryn39n39rM the n PhD MSVVIIEC5 A Informed Consent 0 Essential to ethical conduct 0 Potential subject chooses whether or not they will participate o Obtained after full information understood o Explanation of study objective otential benefits risks inconveniences rights and responsibilities Taryn nrM V tten PhD new FesA 3982 9162005 Informed Consent Introduction Purpose of the Study Procedures Potential Risks and Discomforts Anticipated Benefits to Subjects Anticipated Benefits to Society Alternative to Participation Emergency Care and Compensation for Injury Payment for Participation Financial Obligation Privacy and Confidentiality Participation and Withdrawal Rights of Research Subjects Signatures Tarynn M V tten PhD MSW FGSA Ensuring Adequate Informed Consent How can we be sure that our informed consent process is sufficient IIdeas 9162005 Taryn n M V tten P hD MSW FG A 184 Informed Consent with minors As CTN0002 includes participants ages 15 17 all minors except those legally emancipated will be required to 1 have parentalguardian consent and I provide their assent to participate in the study 9162005 Tarynn M V tten PhD MSW FGSA Common Consent Deficiencies 1 Signed after study procedures started 1 Signed by the subject but not witnessed as required J Incorrect consent form used 1 No modification done when needed 1 No IRB datestampversion control 9162005 Tarynn M V tten PhD MSW FGSA Advertising lAII advertising including flyers must first be approved by the IRB before being posted lWording and formatting of the ad are reviewed for possible coercion W 9162005 Taryr M IvlttGII r nD MSW FGSA a n Payments to research subjects Should Be enough to enable recruitment Be for time and inconvenience Should not Be so much as to induce subjects to go against betterjudgmen t Be for risk taking Be for taking medications 9162005 Tany n39n M V tten P hD MSWgtFG A Areas Which Require Prompt Reporting to IRB Institutional Officials and the FDA I Unanticipated problems involving risks I Noncompliance with IRB requirements or Federal egulsations I Suspension of IRB approval 9162005 Tany n39n M V tten P hD MSWgtFG A PSST Can you keep a secret aka Certificates of confidentiality Tatyn niM V tten P hD mew FGSA Certificate of Confidentiality Protects Investigator from being forced to release any research data in which subject is identified Even under court order or subpoena 9162005 Taryn n M V tten PhD MSW FGSA Certificate of Confidentiality DOES NOT PROTECT Childelder abuse Danger to self or others State requirement for reporting communicable diseases 9162005 Taryn n TM V tten thD MSW FGSA 92 Ensuring Confidentiality 0 Imply assurance to keep information a secret Limited sharing of information 9162005 Tarynn M V tten PhD MSW FGSA I he Paramount imPortance ot the Protection of People Participating in Projects aka Human Subjects Pratection I A participant is regularly brought to the clinic by a good friend One day the friend comes to the clinic to ask if the participant is there How do you respond Why 9162005 Taryn n M V tteh thD MSW FGSA I he Paramount ImPortance ot the Protection of People Participating in Projects aka Human Subjects Protection I Someone calls the treatment facility inquiring about what type of services are provided How might this be a39 possible breach of confidentialty Why 9162005 Taryn n M V tteh thD MSW FGSA I he Paramount ImPortance ot the Protection of People Participating in Projects aka Human Subjects Protection I Two clients get to know each other while they are in the treatment program together At followup time one of these clients asks how the other is doing How do you respond Why 9162005 Tanyh n iM V tteh P hD MSW FGSA Data Collection 391 The quality or integrity of the data is critical Administering forms questionnaires interviews Scoring and interpretation Completing data entry 9162005 Tarynn M V tten PhD MSW FGSA 9162005 Forms completion Tarynn M V tten PhD MSW FGSA Key points on data integrity I How the information is collected I How the information is transferred into data I How data is checked I How data gets to the data center 9162005 Taryn n M V tten thD MSW FGSA Forms completion J Complete all forms 1 Ask all questions I Ask the question as it is written 1 Make sure the response answers the question you asked 1 Client gives information YOU do the coding Fill in any bubbles all the way 1 Notes and more notes I Neatness counts 1 If you are uncertain on how to complete a form get clarification 9162005 Tarynn M V tten PhD MSW FGSA 100 Data Entry Methods Any data entry technology can be GREAT 1 Key methods ScanTron TeeForms Direct computer entry 9162005 Tarynn M V tten PhD MSW FGSA 101 9162005 Procedural Issues Tarynn M V tten PhD MSW FGSA 102 9162005 Record Keeping I Why bother Answer questions External audits Legal ethical requirements Trust Taryn niM V tten PhD new FesA 103 Record Keeping The Heart of the Clinical Study J Source Documents May include hospital charts physician s notes laboratory reports diagnostic test results drug accountablity records etc J Consent Documentation 1 Case Report Forms CRF s 9162005 Tarynn M V tten PhD MSW FGSA 104 Record Keeping Unacceptable white outcrossovers never obscure original data backda ng 9162005 Acceptable initialdate correction late entry notes or addendum if clearly identified as such Tarynn M V tten PhD MSW FGSA single line through error add correct information 105 The Facts About Source Documents I FDA Guidance related to Source Documents in clinical trials International Conference on Harmonisation Good Clinical Practice Consolidated Guideline lDefines GCP providing a unified standard for conducting recording and reporting clinical trials I Describes the essential documents that individuallyv and collectively permit evaluation of the conduct OT r a clinical study and the quality of the data produced 9162005 Taryn39n iM V tten PhD MsvvicsA 1165 The Facts About Source Documents 1 FDA Guidance Related to Source Documents in clinical trials The ICH guide is the only place where the terms source data and source documents are rst defined for clinical trials 9162005 Tarynn M V tten PhD MSW FGSA 107 The Facts About Source Documents I Source Data All information in original records and certified copies of original records of clinical findings observations or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial Source data are contained in source documents 9162005 Taryn39n iM V tten PhD newnessA 198 Examples of Source Data I Medical history I Patient ID number information I Study number I tIees llcsal examination I Drug dispensing I All lab results 39 format39on l I Concomitant meds I Informed Consent I IRB approval I Demographic data DOB sex weight I ViSit dates Age race height I Intijercurren t illness 9162005 Taryn n lM V tten P hD new FGSA 109 Examples of Source Documents l Hospital records I Office charts l Lab reports lX mw l Case report forms I Memoranda directly I l Subject diaries I Magnetlc medla l Pharmacy dispensing I PhOtQQTQPhiC records negatives 9162005 Tany n n M V tten PhD MSW FGSA when data is entered 11770 Progress Notes Elements 1 What happened I What did not happen 1 Notable information SAE s protocol deviations protocol deviations something everyone needs to know 1 Plans 9162005 Tarynn M V tten PhD MSW FGSA 111 9162005 Alphabet Soup l AE l IND J SAE 1 UCLA FDA 1 NIDA l CTN 1 QA 1 SOP 1 MFT Tarynn M V tten PhD MSW FGSA 1 CTP 1 PI 1 RA SAC J MD 1 CRF CFR l GCP l IRB I CDAC 112 Progress Note Basics DO 1 Complete on same day Use names 1 lncludefull date and sometimes time of day 1 Include key elements Signature and sometimes title of note Leave blank lines maker Write a book chapter Use more codes than words Use whiteout 9162005 Tarynn M V tten PhD MSW FGSA 113 Progress Note Example 1 good or bad I 712 Patty came to the clinic and she was very upset because her boyfriend got kicked out of the program after yelling at the counselor last night Even though Dr Smith told me it was okay I didn t like the way they treated him either so I told Patty I agreed with her and I gave her some numbers to call She couldn t pee because she had just gone to the bathroom when she stopped on the way to the clinic so I just got the data and told her itwas ne 9162005 Taryh n iM V tten PhD Mswi csA 1121 Progress Note Example 2 bad or good 1 71800 Ct saw PA for PE ok ASI wo SecD RTC TB 720 UA BZE AMH 1 72000 Ct no showed 9162005 Tarynn M V tten PhD MSW FGSA 115 Progress Note Example 3 just plain bad I 72000 Mrs Yamhill completed all data for week 4 provided urine sample RTC on 72100 I 71900 Mrs Y came to the clinic are I gave her the Informed Consent and puushed put her in the waiting room to read it She readq39xm then came into the office and we went over it and she signed it39 I 72100 Mrs Yamhill call and said that she couldn t come to clinic because her boyfriend Bob S39mithkins was upset because he just tested positive for HIV and has KS 9162005 Taryn39n iM then PhD MSWFG A 115i Progress Note 102500 Screening visit CRC Client presented informed consent document to review discussion and questions answered Client verbalized an understanding of study including risks and ability to withdraw at anytime Client signed informed consent copy provided Screening visit completed Client meets eligibility criteria Appt forquot enrollment 102700 1300hrs CRC C Clark CRNP 9162005 Taryn n M V tten thD MSW FGSA 117quot Ability to withdraw at anytime Client signed consent Copy of informed consent provided to client Screening visit completed If client meets inclusion exclusion criteria set enrollment visit appointment Next Appointment Complete data forms send to DMU Complete progress note Signature 9162005 Tarynn M V tten PhD MSW FGSA Client Safety and Adverse Events Safety Monitoring Associated with recognizing and reporting of adverse events related to trial participation and positive outcomes 9162005 Taryn n M V tten thD MSW FGSA 120 Participant Safety and Adverse Events Any untoward medical occurrence in a participant which may or may not have a causal relationship with the study treatment Treatment related AE s occurring during treatment or within 30 days after final administration of treatment i39e last dose of study drug or last session of psychosocial treatment are to be followed until resolution pr stabilization 9162005 Taryn n M V tten PhD Msw FesA I121 REPORTING AE s adverse events unless serious can usually be reported on CRF Report all symptoms and untoward events whether or not they are believed to be related to study medication Expedited reporting 9162005 Taryn n M V tten PhD MSW FGSA 12392 Is It Study Drug Related 1 Was it present at baseline 1ls it a known side effect of the medication lWhat else is going on that might explain it I Participant selfreport is important 9162005 Tarynn M V tten PhD MSW FGSA 123 AE SEVERITY I Mild tolerable pt aware of it I Moderate caused enough discomfort to interfere with activity or caused client to intervene in some way eg prescription or OTC medication I Severe caused incapacity to do work or usual activity May be a Serious AE I Life Threatening Definitely a Serious AE 9162005 Taryh n iM V tten Pm MSW FGSA I124 Who Assesses AE s I Primarily the study physician IAIso study pharmacist or nurse I It is important for ALL STAFF in contact with the participant to record any AE that might be reportedremember you may be the ONLY person they inform about this AE 9162005 Taryn39n iM V tten PhD MSW FGSA I125 SERIOUS AE s result in I Death I Life threatening event I Persistent or significant disabilityincapacity I Inpatient hospitalization or prolongation of a current hospitalization I Congenital anomaly or birth defect I Events that do not result in death or require hospitalization but DO require INTERVENTION to prevent death a life threatening situation or inpatient 916200hospitalizationawh39n v Men PhDi MsWYFGSA Adverse Event I On Wednesday participant XY shows up for his visit on crutches You of course ask him what happened and he replies Oh I was hit by a car after I saw you on Monday his last visit two days ago You quickly think to ask more questions recognizing that an Adverse Event has occurred He assures you that this wasn t due to the study but was the fault of a driver paying no attention He reports that he attempted to walk across the crosswalkon the red light only to have the car run the light and hit I Was this really an AE An SAE I What questions will you ask to determine if this was an AE oriSAE Adverse Event 1 You receive a phone call from the wife of X2 in which she informs you that her husband will not be in for his appointment as he has stepped on a nail She is calling you from the hospital where he is about to be seen by an ER doctor You hear little alarms going off in your head as you recognize immediately that this is an Adverse Event 1 Was this really an AE An SAE J What questions will you ask to determine if this was an AE or SAE Adverse Event I Participant FRAK calls you on a day when she was due to come into the clinic and informs you that she checked herself into an inpatient detox program at University Hospital She had previously discussed this possibility with you so you aren t surprised Now you realize you might need to record this as an Adverse Event so you ask FRAK if she will call you back after you have had a chance to consult other study staff I Was this really an AE An SAE I What questions will you ask to determine if this was an AvE or SAE Adverse Event I Upon arriving to work you retrieve a voicemail message from participant THEW who states that she will not be in today as she is recovering from a39 pool accident She was chasing her daughter and accidentally slipped into her friend s pool The friend was nearby and witnessed the entire thing Fortunately the friend knew CPR and was able to revive THEW who was allowed to leave the hospital after only 12 hours of observation This sounds just like that AE stuff you have read about r I Was this an AE An SAE I What questions will you ask to determine if this was an AE oriSAE Communicating Serious Adverse Events Your study team especially PI RB Sponsor eg NIDA FDA for medication trials Tany n nVM vmnen P hD MSW FGSA 9162005 Quality Assurance Everyone is responsible to produce quality work Prevention is the rst step Exercise diligence and thoroughness Follow protocol and operational procedures Become familiar with QA plan Tarynn M V tten PhD MSW FGSA 132 When a Participant Leaves the Study Follow Up Why it important Planning for fo39l p g Tany n39an vmnen P hD MSWFG A 9162005 Client Follow up Critical to research Begins with first visit Taryn n M V tten P hD MSW FGsA 134 39 mandates IRES andat National mun fur Pmt e ion International Conference on Harmonization Tripartite input from regulatory industry consumer Effective 1997 guideline defines Good Clinical Practice Standard for designing conducting recording and reporting trials that invd lvethe participation of human subjects 9162005 Taryn n M V tten P hD MSW FGSA 1377 Examples of Key Data Methods Method The Good The Bad The Reality Double key entry ScanTron TeIeForms Direct computer entry 9162005 Taryn n M V tteh PhD mew FGeA 138 Visit date 102500 9162005 Visit type Screening Introduce self to client Introduce study to client Provide informed consent document to client for review Ask client not to sign until after review Determine if client needs informed consent read to them Determine clients understanding of study requirements Visit schedule Risks benefits compensation Taryn n M V tten P hD MSW FGsA 1319 9162005 The End Tarynn M V tten PhD MSW FGSA 140 CERTIFICATES OF CONFIDENTIALITY Certificates of Confidentiality I Issued by the National Institutes of Health NIH I Protect investigators and institutions from being compelled to release information that could be used to identify research study participants I Allow the investigator and others who have access to research records to refuse to 916200diSCIOSe 142 I ninil
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