Clinical Trials Registration - University of Wisconsin–Madison

Clinical Trials Registration:Your ObligationsJames Wells, PhDOffice of Research PolicyGraduate SchoolShari Zeldin, BS, CCRCUW Comprehensive Cancer CenterUniversity of Wisconsin-MadisonCommittee on Clinical Trials Registration

Introduction2 Clinical trials registration in ClincialTrials.gov isrequired. UW-Madison wants to ensure that trials areappropriately registered. Failure to register can have severeconsequences. Investigators may have been unaware of theserequirements. Newly developed procedures and guidelinesshould help.UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

FDA Requirements All Phase II-IV interventionaldrug, biologic or devicetrials. (Not Phase I trials.) Whether or not trial supportsa new FDA application Registration due 21 days after the first patientis enrolled3UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

FDA Requirements All Phase II-IV interventionaldrug, biologic or devicetrials. (Not Phase I trials.) Whether or not trial supportsa new FDA application Registration due 21 days after the first patientis enrolled4UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

FDA Consequences Penalties for failure toregister or providing false ormisleading information Federally funded trials maybe penalized by withholdingof funds Civil penalties $10,000 per violation After notification, up to $10,000 per day5UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

ICMJE Requirements Any research study thatprospectively assigns . . . toone or more health-relatedinterventions to evaluate theeffects on health outcomes Includes Phase I Drugs, surgical procedures, devices,behavioral treatments, dietary interventions,and process-of-care changes Prospective registration, i.e., registered inClinicalTrials.gov before the first patient isenrolledUW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION6ICMJE

International Committee of Medical Editors Who is ICMJE? Uniform Requirements forManuscripts Submitted toMedical Journals 714 journals use the Uniform Requirements www.icmje.org/jrnlist.html7ICMJEUW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

ICMJE Consequences Unregistered trials will not beconsidered for publication injournals that adhere to ICMJEstandards.8ICMJE Prospective registration required for trialsbegun after July 1, 2005 Contact the editor if you have questionsUW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

Comm. on Clinical Trials Registration9 Membership Administrative Legal Services Carbone Cancer Center (UWCCC) Institute for Clinical & Translational Research (ICTR) Office of Clinical Trials (OCT) Office of Research Policy (ORP)UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

What’s New Need to consolidate resources on campus andhave a presence Publicize the requirement Website www.grad.wisc.edu/research/hrpp/ctregistration Identify Clinical Trials at IRB application stage10 Provide guidance and assistanceUW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

Registering trials on ClinicalTrials.gov11UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

Registering trials on ClinicalTrials.gov12 WHO is responsible for registering the trial? WHAT trials need to be registered? WHERE do you go to register? HOW do you register? WHEN do you register?UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

Registering trials on ClinicalTrials.gov13 WHO is responsible for registering the trial? Investigator-initated trials- PI registers the trial Industry-sponsored trials- Sponsor registers thetrial NIH-funded trials- Grantee of funds registersthe trial Trials involving an IND/IDE- Holder of IND/IDEregisters trialUW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

Registering trials on ClinicalTrials.gov14 WHAT trials need to be registered withClinicalTrials.gov?All “applicable clinical trials”, whetherfederally or privately sponsored. Applicable studies include all Phase II – IVinterventional drug, biological or device trials. Phase I are required to be registered forpublication by ICMJEUW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

Registering trials on ClinicalTrials.gov15 WHERE do you go to register your trial onClinicalTrials.gov? https://register.clinicaltrials.govUW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

Registering trials on ClinicalTrials.gov16 HOW do you register your trial? Obtain a username and password from theappropriate UW ClinicalTrials.gov administrator:Shari Zeldin – UW Cancer Center- for allcancer-related trialsswzeldin@uwcarbone.wisc.eduTina Graber- Office of Clinical Trials- for allother trialstmg@clinicaltrials.wisc.eduUW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

Registering trials on ClinicalTrials.gov17 HOW do you register your trial? After logging in, you will see the Main Menupage. Under Protocol Record, click ‘Create’ andcomplete the study description template. To get a detailed explanation of a specific datafield, click on the name of the data field. Required fields are marked with an red asteriskor a green FDAAA logo.UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

Registering trials on ClinicalTrials.gov18 TIPS for registering your trial You do not have to complete a record all at once. Youcan save and come back to it. Once you complete your protocol record, you need toclick ‘Complete’. The protocol record is then sent automatically to theadministrator for ‘release’. If the record is incomplete, the administrator will send itback to you for completion. There should be noWARNING notices on the top of your record. If there are,that is an indication that your record is incomplete.UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

Registering trials on ClinicalTrials.gov19 More TIPS for registering your trial The administrator will ‘release’ the record when it iscomplete. ClinicalTrial.gov then conducts a QA review on theprotocol record. If the protocol record passes the QAreview, the protocol will appear on the ClinicalTrials.govwebsite within 2-5 days. Consider this timeframe when deciding when tocomplete the protocol record, ensuring that you get theprotocol registered before the first subject goes on study(per ICMJE requirements) or within 21 days of firstsubject on study (FDA requirement).UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

Registering trials on ClinicalTrials.gov20 HOW do you update your clinical trial record? You are required to keep your clinical trialrecord up to date. You must update the protocol record within 30days for changes in recruitment andcompletion. All other changes can be reported every 12months. Even if there are no changes, the protocolrecord must be verified every twelve months.UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

Registering trials on ClinicalTrials.gov21 HOW do you update your clinical trial record? To update, on the Main Menu page, click‘Modify’ under Protocol Records. Then go to your protocol and ‘edit’ the datafields that require updating. Make certain, each time you go in to theprotocol record, that you update the‘Registration Verification Date’.UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

Registering trials on ClinicalTrials.gov22 WHEN must you register your trial? You must have your trial registered before the firstsubject on trial (per ICMJE) or within 21 days offirst subject on trial (per FDA) WHEN must you report Results and Adverse Events? Results reporting must be submitted no later thanone year after the earlier of: The estimated completion date of the trial (whichcan be changed along the way), or The actual date of completion Adverse Events must be part of the resultsreporting.UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

Websitewww.grad.wisc.edu/research/hrpp/ctregistration

FDA Information PageResourceswww.fda.gov/ScienceResearch/SpecialTopics/-RunningClinicalTrials/default.htm FDA Amendments Act of 2007frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=-110_cong_public_laws&docid=f:publ085.110.pdf ICMJE Clinical Trial Registration FAQ’swww.icmje.org/faq.pdf NIH Guidance on New Results Database24www.nlm.nih.gov/news/expanded_clinicaltrials.htmlUW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

Contact the Presenters25UW-Madison Office of Research PolicyJames A. Wells, PhDDirector(608) 262-0558jawells2@bascom.wisc.eduUW-Madison Comprehensive Cancer CenterShari Zeldin, BS, CCRCResearch Program Manager(608) 263-8403swzeldin@uwcarbone.wisc.eduUW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION

26QUESTIONS?UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION