Category Archive: 2017 Programs and Resources

Responsible Party


The Responsible Party (RP) for a clinical trial must register the trial and submit results information. An RP can be: The Sponsor of the clinical trial (as defined in 21 CFR 50.3) who initiates the study (i.e., “Johns Hopkins University”) The Principal Investigator (PI) The Sponsor-Investigator (the individual who both initiates and conducts the study) –Per updated Policy 103.25 “Organization Policy on Registration of Clinical Trials” Johns Hopkins University (JHU) must be identified as the RP –Benefits of assigning JHU as the RP Careful review of potential issues based on our prior experiences Reduction in the number of comments you will […]

Trials to Register and Report


There are 4 basic categories under What Trials to register and report: Clinical Trials funded either in whole, or in part by National Institutes of Health (NIH) (applicable to all NIH-funded studies independent of whether the study meets the definition of an applicable clinical trial as detailed below): https://www.gpo.gov/fdsys/pkg/FR-2016-09-21/pdf/2016-22379.pdf Trials that meet the clinical trial definition of The International Committee of Medical Journal Editors (ICMJE) that the investigator may wish to publish: ICMJE journals will consider [for publication] trials beginning on or after July 1, 2005 only if registration occurred before the first patient was enrolled (“prospective registration”). http://www.icmje.org/about-icmje/faqsclinical-trials-registration/ Qualifying clinical trials […]

Registering and Reporting


Why Register and Report? Commitment to research participants Scientific validity/transparency Ethical standards Responsible stewardship of federal funds Required by law (FDAAA) * NEW* Required for any clinical trial funded in full or in part by NIH Required by NCI Required for journal publication (ICMJE) Required for CMS Required by WHO Who is Responsible for Registering a Trial? The Responsible Party (RP) for a clinical trial must register the trial and submit results information. An RP can be: The Sponsor of the clinical trial (as defined in section 21 CFR 50.3) who initiates the study.  The Johns Hopkins PI should consult […]

Program Highlights


Program highlights: 2.5 FTEs of dedicated staffing Prince Nuamah, MD, MPH Oswald Tetteh, MD, MPH Anthony Keyes, MBA, PMP Statistical expertise Provided by the BEAD Core http://jhcchr.org/bead First 1-hour covered by the program Most concerns can be handled in the 1-hour consultation Additional time needed and costs can be discussed Study team assistance Registration Account creation and maintenance Initial registration -Required for Applicable Clinical Trials -NEW: required for any clinical trial receiving full or partial NIH funding PRS reviewer comments (now time-limited to 15 calendar days) Update reminders (required every 12 months regardless of changes) Results reporting Changes to PI/Study team […]

Timeline


  Year Entity Event 1997 Congress 1st U.S. law to require trial registration (FDAMA) 2000 NIH Releases ClinicalTrials.gov website 2005 ICMJE Requires registration before enrollment 2006 WHO All clinical trials should be registered 2007 CMS PI must enroll qualifying clinical trials in ClinicalTrials.gov 2007 Congress Expanded registration, submission of results and adverse events, civil penalties (FDAAA) 2008 NIH Releases results database 2015 CMS Mandatory Reporting of Clinical Trial Number on Claims  

ClinicalTrials.gov Program


The ClinicalTrials.gov program assists investigators with: The ethical, scientific and legal reasons for clinical trials registration and reporting Which trials are required to be registered and the timelines Tips, tricks and helpful content to improve the process Up-to-date information on institutional and federal policies Direct effort upon request (billable/hr.) Annual Reports 2019 2018 Publications BioMed Central Publication (Supported by the ICTR detailing survey results of academic organizations) Mayo-Wilson E, Heyward J, Keyes A, Reynolds J, White S, Atri N, Alexander C, Omar A, Ford DE, on behalf of the National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee. Clinical […]

Charges For Clinical Research Unit Services


Effective May 2018, Clinical Research Units are now operating using a service center model. The National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH), which supports the ICTR Clinical Research Units (CRUs) through its Clinical and Translational Science Award (CTSA) program, announced in 2014 that direct support of the CRUs will not be allowed for any new or re-competing CTSA awards. Our CRUS have been a major source of support for investigators throughout Johns Hopkins and this change in policy will have a significant impact on our future ICTR operations. Consequently, in May 2018, our CRUs […]

Protection of Patient Data


Johns Hopkins has multiple IT policies regarding the protection of patient data. Diana Gumas, Senior Director for Clinical Research Information Technology, is responsible for working with the Johns Hopkins Medicine Data Trust, the Institutional Review Boards, and the clinical research community to facilitate compliance with policies and address and resolve special data protection needs. The goals of our data protection policies are to ensure compliance with all applicable federal, state, and local law; to safeguard and protect all IT Resources from anything other than authorized and intended use; and to provide protection to academic, clinical, financial, research, and all other […]

Future Charges For CRU Services


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Research Electronic Data Capture (REDCap)


Research Electronic Data Capture (REDCap) is a mature, secure web application for building and managing online surveys and databases.   Using REDCap’s stream-lined process for rapidly developing projects, you may create and design projects using the online method from your web browser using the Online Designer and/or the offline method by constructing a ‘data dictionary’ template file in Microsoft Excel, which can be later uploaded into REDCap. Both surveys and databases (or a mixture of the two) can be built using these methods. REDCap Provides automated export procedures for seamless data downloads to Excel and common statistical packages (SPSS, SAS, […]

Recruitment Innovation Unit Consultation


We provide consultation and coaching on the recruitment and retention of diverse research participants using evidence based and field tested methods.  Our team offers advice and guidance to help investigators and research staff identify and address recruitment barriers. Our consultants have experience with technology and community-engaged recruitment strategies. We provide recruitment support in the following areas: Needs assessment Study design assessment Pre-screening/cohort discovery Outreach to stakeholder partners Customized recruitment and retention plans Troubleshooting recruitment challenges Gathering feedback from the ICTR Community Research Advisory Council (C-RAC) Creating a recruitment timeline Developing strategies to increase enrollment ans retention Assessing feasibility of recruitment […]