orientation for new clinical research personnel module 1 presented by nc tracs institute unc office...

ORIENTATION FOR NEW CLINICAL RESEARCH PERSONNEL MODULE 1 Presented by NC TraCS Institute UNC Office of Clinical Trials UNC Network of Clinical Research Professionals

OVERVIEW OF ORIENTATION PROGRAM & INTRODUCTION TO CLINICAL RESEARCH Marie Rape, TraCS Regulatory Core

Overall Agenda for Orientation Module 1: Introduction to Clinical Research, Education, and IRB Module 2: Study Implementation, Documentation, and GCPs Module 3: Contracting, COI, and Hospital Administrative Elements Module 4: Clinical Trial Management, Budgeting, Hospital and Research Accounting

Module 1: Introduction and IRB Overview of orientation program Marie Rape Introduction to clinical research Marie Rape UNC Network of Clinical Research Professionals, available educational programs Michelle Duclos OHRE and IRB overview Tim Kuhn

Module 2: Study Implementation and Good Clinical Practices Roles of research personnel, study implementation Michelle Duclos Good Clinical Practices (GCP) and study documentation Marie Rape Informed consent process, HIPAA Claudia Christy

Module 3: Contracting and Hospital Administrative Elements Conflicts of interest Joy Bryde Contracts and clinical trial agreements Aylin Regulski ClinicalTrial.gov and ICMJE requirements Monica Coudurier Investigational Drug Service Sue Pope Investigational Device Policy Aylin Regulski

Module 4: Clinical Trial Management, Budgeting, and Accounting Overview of the Clinical Research Management System (CRMS) Ed Finerty/Laura Cowan Hospital 98 accounts and research billing Nancy Rose and Amelia Rountree Budgeting and accounting of research funds Jill Cunnup Medicare coverage analysis Jill Cunnup

Overall Objectives Define human subject / clinical research Discuss various options available for training of research personnel Review human subject research protection and the IRB Define appropriate responsibilities for study team members Describe steps for successful implementation of a study Describe appropriate management of study documentation Define Good Clinical Practices (GCP) Review the informed consent process Discuss research compliance and required approvals at UNC Review basic elements of contract negotiation and grant management Review use of the Clinical Research Management System (CRMS) Describe process for managing hospital research accounts and bills Describe steps for managing budgets and accounting of funds

SpeakerOffice / Dept. Represented Phone number Email Marie RapeNC TraCS919-966-6844 [email protected] Michelle DuclosNCRP919-484-0931 [email protected] Tim KuhnOHRE / IRB919-843-3854 [email protected] Claudia ChristyNC TraCS919-843-9445 [email protected] Joy BrydeCOI office919-843-5328 [email protected] Aylin RegulskiOCT919-843-7894 [email protected] Monica CoudurierOCT / CT.gov919-843-2333 [email protected] Sue PopeIDS919-966-2371 [email protected] Ed FinertyCRMS919-843-2861 [email protected] Laura CowanCRMS919-843-0726 [email protected] Nancy RoseHosp. Accounting919-966-4887 [email protected] Amelia RountreeHosp. Billing, 98#919-966-7603 [email protected] Jill CunnupBudgeting919-966-0134 [email protected]

Who should attend Orientation? Personnel involved in clinical (human) research Study coordinator Social/Clinical research assistant Research nurse Research associate Regulatory personnel Investigators Involved in any type of clinical research Social Behavioral research Clinical trials Investigator initiated research Federal grants Biomedical research

Definition of Clinical Research Clinical Research defined by NIH as Patient-oriented research: research involves a particular person or group of people or uses materials from humans. Studies of mechanisms of human disease Studies of therapies or interventions for disease Clinical trials Studies to develop new technology related to disease Epidemiological and behavioral studies: studies examine distribution of disease, factors that affect health, how people make health-related decisions. Outcomes and health services research: studies seek to identify the most effective and most efficient interventions, treatments, and services.

Conducting Quality Research The overarching objective of clinical research is to develop generalizable knowledge to improve health and/or increase understanding of human biology However, research asking socially valuable questions can be designed or conducted poorly leading to scientifically unreliable or invalid results. Study personnel are key to conducting quality research! Knowledge of research best practices, good clinical practices, keeping abreast of regulatory requirements, and training needs are key to conducting quality research.

Knowing the Resources Available TopicUnit/OfficeWebsiteTelephone Training for Research Staff Network for Clinical Research Professionals (NCRP) http://tracs.unc.edu/clinical-research/network- for-clinical-research-professionals-ncrp.html na Resources, NCRP, CRMS, upcoming eventsResearch Central http://tracs.unc.edu/clinical-research/clinical- research-management-system-crms.html na Human subjectsOffice of Human Research Ethics http://research.unc.edu/offices/human- research-ethics/index.htm 919-966-3113 Online IRB applicationOHRE https://apps.research.unc.edu/irb/ na Human subjects research, GCP, and RCR training CITI on-line training http://research.unc.edu/offices/human- research- ethics/researchers/training/index.htm na HIPAA Policies, TrainingHIPAA online Training http://www.med.unc.edu/security/hipaa Research facts and figures about UNCUNC Research http://research.unc.edu/index.htm na Sponsored projectsOffice of Sponsored Research (OSR) http://research.unc.edu/offices/sponsored- research/index.htm 919-966-3411 Proposal & Award DevelopmentRAMSeS https://apps.research.unc.edu/ramses/ 919-966-3411 Clinical Trials, Contracts, CT.govOffice of Clinical Trials http://research.unc.edu/offices/clinicaltrials/index.htm 919-843-2698 Investigational DrugsInvestigational Drug Service (IDS) http://pharmacy.intranet.unchealthcare.org/se rvices/investdrugs 843-9919, (manager) Clinical research support/GuidanceNC TraCS tracs.unc.edu 966-6022 Submission Tool, 98 account, budgetingClinical Research Management System http://tracs.unc.edu/clinical-research/use- crms.html 843-0726 (Laura) Research Studies RecruitmentFind Clinical Research at UNC http://tracs.unc.edu/index.php?option=com_tr acs_forms&view=rro&layout=searchable&Ite mid=1267 na Clinical Research UnitCTRC http://tracs.unc.edu/ctrc/clinical-and- translational-research-center.html 843-1070 Data and Safety Monitoring BoardsTraCS DSMB http://tracs.unc.edu/regulatory-services/nc- tracs-institute-dsmb.html 919-966-6844 IND/IDE GuidanceTraCS IND/IDE Program http://tracs.unc.edu/regulatory- services/ind/ide-support.html 919-843-9514 Cancer Research Lineberger Comprehensive Cancer Center (LCCC) http://unclineberger.org/ 919-966-3036 Oncology Protocol ReviewOncology Protocol Review Comm. http://unclineberger.org/home- main/protocolreview 919-966-3036

Training, Training, Training Training is key to keeping abreast of best practices and regulatory requirements. You need to take responsibility for staying informed and educated! Pre-Requisites for Orientation Completion of CITI Good Clinical Practice (GCP) Online Training, available at www.citiprogram.orgwww.citiprogram.org Completion of CITI Ethics Online Course, available at www.citiprogram.org www.citiprogram.org

STUDY COORDINATOR EDUCATION Michelle Duclos, President NCRP

Why Coordinator Education? The investigator should ensure that any individual to whom a task is delegated is qualified by education, training and experience (and state licensure where relevant) to perform the delegated task. Documentation of training is essential for meeting the guidelines put forth by regulatory agencies for the conduct of Human Subject Research.

Study Coordinator Education Documentation of Coordinator Education may be part of the investigator/ department/division/center processes. This may include (dependent on type of research being conducted) Completion of Human Research Ethics Training Completion of Good Clinical Practices Training CV and/or state licensure Job Skill Training (such as conducting an EKG) Training plan per your specific job title Documentation of Training for each protocol

Example Training/Education Checklist

Example Matrix of Training

Study Coordinator Education OHRP Office of Human Research Protection Responsibilities of UNC Before any human subjects research can be conducted, the institution must provide the department or agency a written Assurance that it will comply with the requirements of the Policy www.hhs.gov/orhp The HHS regulations are intended to implement the basic ethical principals governing the conduct of human subject research General Responsibilities All parties involved, institution, investigator, and IRB must actively engage in ensuring human subject protection and this is only achieved through proper training/education of all research professionals

The purpose of the UNC-NCRP is to promote excellence in the conduct of clinical, social, behavioral, and translational research through a forum of education, professional development and mentoring programs

NCRP Educational Programs Lunch and Learns/Educational Seminars Mentoring Certification Committees Best practices Education Mentoring Listserv

Current Projects Developing a career ladder with Office of Vice Chancellor for Research Developing a coordinator handbook release date Oct 2012 Organizing ACRP/SoCra Certification study groups - ongoing Working towards developing a social/behavioral research coordinator handbook Developing a Recruitment Toolkit to be available on website Developing SOPS and best practices, available on website release date Oct 2012 Education through DID YOU KNOW series sent out via list serv Increasing awareness of NCRP NCPR wants to help you! Please let us know what you need to do your job better!

Go to: http://tracs.unc.edu/clini cal-research/education- sessions.html http://tracs.unc.edu/clini cal-research/education- sessions.html For a list of upcoming NCRP Education Sessions. Go to: http://tracs.unc.edu/clini cal-research/education- sessions.html http://tracs.unc.edu/clini cal-research/education- sessions.html For a list of upcoming NCRP Education Sessions. CEUs may be offered for select programs. CEUs may be offered for select programs.

Who to Contact To join the list serv, contact Michelle Duclos at [email protected] [email protected] To serve on a committee, contact the committee chair Information regarding committees and upcoming events can be found on our web site www.uncncrp.org

IRB OVERVIEW Tim Kuhn IRB Training Coordinator Office of Human Research Ethics

Objectives List three types of IRB review Describe two IRB-related responsibilities for investigators after receiving IRB approval for a study Describe which Events ARE reportable to the UNC IRB State what the UNC-CH IRB requires for ethics training Update on On-line IRB submissions Questions

ohre.unc.edu Regulatory Documents: OHRE Standard Operating Procedures (SOPs); IRB Rosters For Researchers: Submission Instructions; Frequently Asked Questions (FAQs); Student Guidance Deadlines and Meeting Dates Access to Ethics Training (CITI: Human Subjects Protection IRB Modules) On-Line Submissions: Web portal for reporting UPs/AEs; On-line Application; On-line Submission FAQs; Training Videos and Printable Aids Resources: Links to useful information

US REGULATORY REQUIREMENTS All human subjects research must have prior approval by an Institutional Review Board Independent review to protect rights and welfare of subjects Informed consent must be obtained (unless waived by the IRB) An Assurance to the federal government binds UNC- Chapel Hill to uphold ethical and regulatory requirements License to receive extramural grants Can be suspended for violations

What is Research? Federal Regulations define Research as a systematic investigation designed to develop or contribute to generalizable knowledge Innovative clinical care is not necessarily research QA/QI is not necessarily research

WHAT IS A HUMAN SUBJECT? Federal Regulations define a human subject as a living individual about whom an investigator obtains... data through interaction or intervention randomized clinical trial exposure to controlled conditions systematic gathering of physiologic or psychological data identifiable private information medical records review study of existing biologic specimens

Compulsive Buying Patterns in College Students Who: Undergraduate students What: surveys of self esteem and buying habits When: class time (tacked on at the end) Where: recruited through university classes Why: assess prevalence of compulsive buying, measure habits against low self esteem measures

Additional details: Questionnaire includes questions about drug and alcohol use (current and past) Consent form requests signature PI requests an exemption

What is an IRB? (Institutional Review Board) A committee mandated by federal regulations. Protects the rights and welfare of human subjects in research activities through independent review of proposed research.

What does an IRB do? Educates researchers about the IRB review process and requirements Approve, disapprove or modify research involving human subjects Conduct continuing review of research Observe, monitor, audit research Suspend or terminate approval of research

IRB Membership At least 5 members, not all men, not all women (UNC IRBs have 10-15 members) Not all members of one profession Diversity Expertise appropriate to the research At least one scientist, one non-scientist At least one member not otherwise affiliated with the institution

UNC-CH IRBs Biomedical (A,B,C,D): Expertise is focused on medical, dental, surgical, physiological, or pharmacological research Non-Biomedical (E): Expertise is focused on research in behavioral and social sciences; the humanities; and research in a public health or nursing context

Growth in Volume and Complexity of Research Requiring IRB Review 1999-2011

Level of Risk Generally Determines Level of IRB Review Exempt Expedited Full Board Review Minimal Risk? RISK Not Human Subjects Research 2. Are there Human Subjects? 1. Is it Research? Is it on the list? 6 Categories defined by Regs Is it on the list? 9 Categories defined by Regs

Types of Risk Physical (e.g. pain, drug side effects, or injury) Psychological (e.g. emotional distress) Social (e.g. stigmatization) Economic (e.g. loss of jobbreach of confidentiality that relates to stigma, or workplace competency issues) Legal (requirements to report some illegal activities, whether the focus of the study, or which emerge without prompting)

Exempt Research 45 CFR 46.101(b) Six categories, defined by regulations PI may request an exemption IRB will make the determination Exempt from continuing review, once approved by the IRB Investigator obligated to conduct research as described in protocol

Exempt Research* 45 CFR 46.101(b) 1. Normal educational practices in established educational settings 2. Educational tests, surveys, interviews, or observation of public behavior -unless identified & sensitive** 3. Research on elected or appointed public officials or candidates for public office * Exception for prisoners ** Exception for children 4. Research using existing data, if publicly available or recorded without identifiers 5. Evaluation of public benefit service programs 6. Taste and food quality evaluation and consumer acceptance studies 42

Expedited Review 45 CFR 46.110 Nine categories, defined by regulations Chair or designated member IRB Members informed Reviewer may not disapprove

1. Risks minimized 2. Favorable risk: benefit ratio 3. Equitable selection of subjects 4. Informed consent sought 5. Informed consent documented 6. Monitoring plan for safety 7. Privacy and confidentiality protected 8. Additional safeguards for vulnerable populations 45 CFR 46.111 and 21 CFR 56.111 Criteria for IRB Approval: Expedited or Full Board review

The IRB Meeting Voting on possible actions

When You Get a Contingency Memo: Dont despair and dont take it personally It is rare for study not to raise at least one question from the IRB The PI should respond point by point in writing to the memo and make the corresponding changes to the application and consent forms

When You Get a Contingency Memo:

Approved! Research may proceed upon receipt of written documentation of IRB approval Investigator has a responsibility to report to the IRB Changes BEFORE they are implemented Unanticipated problems or serious adverse events that may occur during the research

What if you want to change the protocol? Once your study is approved, you may submit modifications All protocol changes must be approved by the IRB before implementation. All changes to documents used with subjects (consent forms, questionnaires, recruitment materials, etc.) must be approved by the IRB before using.

Modifications to Approved Studies The IRB assesses if the modification changes the level of risk: Do subjects need to be made aware of the new information? If a revised consent form is included, is it accurate?

Continuing Review or Renewal No approval is valid for longer than one year from the initial review Expired (lapsed) approval = no approval Must meet same criteria for approval as at initial review IRB continues to review risk: benefit Adverse event reporting Unanticipated problems

Continuing Review or Renewal The IRB assesses whether the study is proceeding as expected: Is the number of subjects enrolled < the number approved? Have there been unanticipated problems or new information that suggests a change in risk:benefit? Are there trends in protocol deviations that may need to be addressed? Do monitoring reports or Data Safety Monitoring Committee reports suggest issues that may need to be addressed? Are there changes requested for the upcoming approval period?

From OHRP Guidance Vast majority of AEs are NOT REPORTABLE Small proportion of AEs are UPs- -REPORTABLE REPORTABLE UPs include events that are NOT AEs Under 45 CFR part 46: Do not report A; Report B and C.

What is a UP? Federal guidance defines as: Any incident, experience, or outcome that meets all of the following criteria: 1. Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied; 2. Related or possibly related to a subjects participation in the research; and 3. Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) related to the research than was previously known or recognized.

Reporting UPs to the UNC IRB An event that satisfies the first two criteria: 1. is unexpected 2. is related or possibly related to participation in research is reportable to the IRB using the on-line system The researcher is asked to provide a risk assessment however, risk will be determined by the IRB.

Likely Outcomes of Reportable UPs According to federal guidance, unanticipated problems involving risks to subjects or others warrant consideration of: 1. Substantive changes to the protocol or informed consent process/document; or 2. Corrective actions in order to protect the safety, welfare, or rights of subjects

UPs vs. AEs Most adverse events (AEs) are not unanticipated problems (UPs) AEs that are expected in terms of specificity, severity, and frequency (e.g., described in the protocol, Investigator Brochure, the literature, or the consent form) are not Ups AEs that are unrelated to the research or there is simply insufficient information to address causality are not Ups AEs that do not place subjects at greater risk of harm than was considered by the IRB when it approved the research are not UPs

Serious Adverse Event (SAE) Any adverse event temporally associated with the subjects participation in research that meets any of the following criteria: 1. results in death; 2. is life-threatening (places the subject at immediate risk of death from the event as it occurred); 3. requires inpatient hospitalization or prolongation of existing hospitalization; 4. results in a persistent or significant disability/incapacity; 5. results in a congenital anomaly/birth defect; or 6. any other adverse event that, based upon appropriate medical judgment, may jeopardize the subjects health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition

Reportable Events Include ALL Protocol Violations

IND Safety Reports Individual IND safety reports from external sites should not be reported to the IRB unless accompanied by an aggregate analysis (e.g., DSMB report) that establishes their significance and a corrective action plan that addresses the problem. IND Safety Reports shall be maintained by the Investigator and should be reported in summary (e.g., not individual reports) to the IRB at the time of continuing review. IND safety reports from external sites that ARE accompanied by an aggregate analysis that establishes their significance (e.g., DSMB report), includes a corrective action plan, and that meet the criteria for a UP should be reported using the on-line system and changes to protocol or consent form should be submitted, if applicable

Data Safety Monitoring Boards (DSMB) Reports Some reports from a DSMB or other independent safety monitoring group provide the aggregate analysis of individual IND Safety Reports, and if this report establishes their significance, includes a corrective action plan, and meets the criteria for a UP, it should be reported using the on-line system and changes to the protocol and consent form should be submitted, if applicable Other reports from a DSMB or other independent safety monitoring group should be provided to the IRB as they become available, or at least as often as the study undergoes continuing review

Time Frame for Reporting Serious Adverse Events (SAE) that meet the criteria for a UP should be reported to the IRB using the on-line system ASAP, but no later than one week All other UPs should be reported to the IRB using the online system ASAP, but no later than two weeks.

Example Nausea during chemotherapy treatment Q1: Did the event occur at a site for which UNC IRB has direct oversight? YES Q2: Was the event unexpected? NO The event IS NOT Reportable

Example Sudden death during chemotherapy treatment Q1: Did the event occur at a site for which UNC IRB has direct oversight? YES Q2: Was the event unexpected? YES Q3: Was the event related or possibly related to the research? YES The event IS Reportable using the on-line system

Example Lost laptop used for research study Q1: Did the event occur at a site for which UNC IRB has direct oversight? YES Q2: Was the event unexpected? YES Q3: Was the event related or possibly related to the research? YES The event IS Reportable using the on-line system

Example Severe psychological stress from completing a survey on risk-prone behaviors Q1: Did the event occur at a site for which UNC IRB has direct oversight? YES Q2: Was the event unexpected? YES Q3: Was the event related or possibly related to the research? YES This event IS Reportable using the on-line system

Example Fainting during blood draw Q1: Did the event occur at a site for which UNC IRB has direct oversight? YES Q2: Was the event unexpected? NO This event IS NOT Reportable

Example IND safety report received by investigator from an external site. The report states that the investigator (at which the event occurred) has determined that the event is reportable. No documentation of aggregate analysis or corrective action plan provided. Q1: Did the event occur at a site for which UNC IRB has direct oversight? NO Q2: Has a determination been made by the Sponsor, DSMB/DMC, etc., that the event meets criteria for UP? NO The event has not been determined to be an UP and is therefore NOT Reportable to the UNC IRB

Example Sponsor letter that provides the findings of interim review identifying previously unrecognized risks. Q1: Did the event occur at a site for which UNC IRB has direct oversight? NO Q2: Has a determination been made by the Sponsor, DSMB/DMC, etc., that the event meets criteria for UP? YES The event IS a UP and therefore IS Reportable to the UNC IRB using the on-line system (and submit changes to protocol or consent form, if applicable)

Protocol Violations and Deviations Protocol Violations are a variance from the study protocol that: Has harmed or increased the risk of harm to one or more research subjects. Has damaged the scientific integrity of the data collected for the study. Results from willful or knowing misconduct on the part of the investigator(s). Demonstrates serious or continuing noncompliance with federal regulations, State laws, or University policies. Protocol Deviations are a variance from the study protocol that: Is generally noted or recognized after it occurs. Has no substantive effect on the risks to research participants. Has no substantive effect on the scientific integrity of the research plan or the value of the data collected. Did not result from willful or knowing misconduct on the part of the investigator(s).

Examples of Protocol Violations Proceeding with the research without IRB approval Failing to follow IRB-approved procedures Implementing any changes without IRB approval Enrollment of subjects who do not meet eligibility criteria Proceeding with research interventions prior to obtaining written informed consent Missed or significantly delayed safety visits or tests. Medication errors

Examples of Protocol Deviations Performing a planned procedure on a different timetable than previously specified in the research protocol because of an unforeseen disruption such as a subjects vacation or illness Study visits out of window (not affecting subject risk) A mechanical failure such as a recording device malfunction Late PK specimens

Reporting Protocol Violations and Protocol Deviations Protocol Violations should be reported to the IRB within one (1) week of the investigator becoming aware of the event using the same online reporting mechanism used to report UPs. Protocol Deviations should be summarized and reported to the IRB at the time of continuing review. Deviations should not be reported individually as they occur.

ohre.unc.edu Regulatory Documents: OHRE SOPs (eg, 19.0 Reporting of UPs and AEs to the IRB and 23.0 Protocol violations, deviations and exceptions) Online Submissions / UPs and AEs Relevant Links: Computer Based Training module Decision tree for determining reportability OHRP Guidance FDA Guidance Web portal for online reporting

When can I close my study? Renew the study as long as data analysis of identifiable data is on-going When you are completely done with all interventions, follow-up and data analysis, the study should be closed If IRB approval of a study expires, no new subjects may be enrolled and all ongoing research activities must stop

OBTAINING CONSENT Obtaining consent is a PROCESS in which... investigator discloses all relevant information potential subject has opportunity to ask questions investigator answers questions subject signs a consent form The consent form is a permanent record of... information conveyed subjects willingness to participate

Written Consent Forms Required elements are covered in templates generated by the on-line application Language must be understandable to subject or representative Some elements, including signatures, may be waived under certain circumstances 45 CFR 46.116, 21 CFR 50.25

REQUIRED ELEMENTS Study involves research Purpose Duration of the subjects participation Description of the procedures Foreseeable risks and discomforts Reasonably expected benefits to subject or others 45 CFR 46.116, 21 CFR 50.25

Alternatives, if any Confidentiality Compensation for injury (> minimal risk)? Contacts for questions about the research, research- related injury, subjects rights Voluntary participation, refusal without loss of benefits, withdraw at any time 45 CFR 46.116, 21 CFR 50.25 REQUIRED ELEMENTS

Human Subjects Protection Training To access CITI, go to ohre.unc.edu / For Researchers / Ethics Training / CITI on-line course If you have CITI training at another institution, add an affiliation at UNC-CH, your training records will be transferred electronically When registering, enter your UNC-CH PID (9 digits, no hyphen, no space). Choose Human Subjects Protection (IRB) modules rather than GCP or RCR training Complete the Basic Course most appropriate to your area of research

Tips for Successfully Navigating the IRB Review Process

Go to: http://research.unc.e du/offices/human- research- ethics/online- submission/training/i ndex.htm http://research.unc.e du/offices/human- research- ethics/online- submission/training/i ndex.htm For a list of upcoming IRB Training Sessions Go to: http://research.unc.e du/offices/human- research- ethics/online- submission/training/i ndex.htm http://research.unc.e du/offices/human- research- ethics/online- submission/training/i ndex.htm For a list of upcoming IRB Training Sessions All sessions are open to the entire campus community; schools are identified for location purposes only and not to identify a limited audience

IRB on-line Contact Information E-mail:[email protected][email protected] Phone:919-966-3113 On-line Help Desk: David Tegnell 919-966-3685

On-line Submissions Smart form approach Single form builds on itself: NHSR Exemption Full application System builds consent forms Electronic Routing and Approvals On-line communication to and from the IRB Include a cover memo that explains special circumstances On-line Submission Training web-based videos and printable aids

Plan ahead! Your application may be one of 100s submitted that week Full Board only meets once per month Pay attention to dates and deadlines Complete the application as directed Provide consents; recruitment materials; and supporting documents If you have questions while completing the application or consents, call 966-3113 or email [email protected]

Transition from Paper to Online Type of SubmissionRoute of Submission New StudiesOnline ModificationsTo new study started online online To existing study started on paper Can stay on paper until next renewal Can submit online, requiring conversion of full application (OPTIONAL) Renewals Ongoing study Data analysis only Online Online but greatly abbreviated Closure Created online Existing on paper Online Online or paper

Reference #: Provide to IRB (Before submission)

Routing of IRB Submissions PI and/or Study Staff Drafts Application Certification by PI (and Faculty Advisor if Student PI)* PIs Home Department (Chair or Dept Review Committee) Administering Department (if any) Oncology PRC or CTRC (if relevant) IRB Non-IRB Issues (if any) *Note that student research will follow same routing process as any project

Department Approvers By approving, the Home or Administering department affirms that: The research is appropriate for the investigator and Department The investigator(s) are qualified to conduct the research There are adequate resources (financial, support, and facilities) available For units that have a local review committee for pre-IRB review, this requirement has been satisfied The department supports the application and its review by the IRB The department agrees to accept responsibility for managing data security risks in consultation with departmental or campus security personnel

Wheres my application?

Check to see who has certified Where IRB Marked Documents Will be located CONFIRM Training and COI Check to see who has been notified to certify

Research Data Security Grading System Subject IDs Sensitive Questions Security Level Requirements* --- IPassword protection YES---IILevel I plus secure network ---YESIILevel I plus secure network YES IIILevel II plus encryption, vulnerability scans, security audits * Note that schools and departments will be expected to play a more central role in ensuring security requirements are met. Investigators should consult with IT managers for their units.

IT Expert within the Approving Department (D epartment Responsible for the Study)

Requesting an Exemption

Consent Process for Exemptions

A.4. Study design, methods and procedures

A.4.A. Biomedical methods and procedures 99

A.4.A. Biomedical methods and procedures

What is a clinical trial? Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. Clinicaltrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.

Consent Form Template What if you have questions about this study? You have the right to ask, and have answered, any questions you may have about this research. If you have questions, complaints, concerns, or if a research-related injury occurs, you should contact the researchers listed on the first page of this form. A description of this clinical trial will be available on www.clinicaltrials.gov, as is required by US law. This web site will not include information that can identify you. At most, the web site will include a summary of the results. You can search this web site at any time.www.clinicaltrials.gov 102

Investigational Drug Service Approval

Investigational Drug Service OHRE SOP 30.8.4 An agent (drug) will be considered investigational if both the following two criteria are met: 1. administration of the agent is part of a protocol that requires IRB approval 2. a subject is required to sign an Informed Consent Form before receiving the agent Researchers using investigational drugs in studies must register all studies with the IDS Pharmacy. Approval letter from IDS should be uploaded in your IRB submission

Investigational Drug Service IDS Website: http://pharmacy.intranet.unchealthcare.org/services/investdrugs/ Contact information, FAQs, IDS forms

Radiation Safety Committee Approval

Radiation Safety Committee OHRE SOP 30.9 Projects in which subjects are exposed to ionizing radiation must receive approval from UNC Radiation Safety Committee before final IRB approval can be granted. Studies involving the use of radiation, such as those requiring patients to be X-rayed, are not eligible for expedited review by IRB, even if all of the other procedures in the study have been deemed to pose no more than minimal risk. Approval letter from Radiation Safety Committee should be uploaded in your IRB submission

Radiation Safety Committee Forms available at http://ehs.unc.edu/ehs/forms.shtml#rad (UNC EHS website, click on forms, Human Use of Radiation in Research)http://ehs.unc.edu/ehs/forms.shtml#rad

Optional Cover Memo to the IRB

IRB Contact Information Website: ohre.unc.edu E-mail:[email protected][email protected] Phone:919-966-3113 Fax:919-966-7879 On-line Help Desk: David Tegnell 919-966-3685 Address: 105 Mason Farm Road Medical School Building 52 (CB # 7097) E-mail (training): [email protected][email protected] Tim Kuhn 919-843-3854 [email protected]

PLEASE VISIT FOR A COPY OF THIS PRESENTATION & ADDITIONAL HELPFUL INFORMATION TRACS.UNC.EDU / RESEARCH CENTRAL