Study Team Tools and Resources
This page contains helpful resources on various research related topics.
Please click on the plus sign for details.
ORA’s Site for Information, Model Agreements and Policies: http://www.hopkinsmedicine.org/Research/ora/agreements/index.html
Core in a Box: The Johns Hopkins University has created and launched a new Web portal dedicated to providing the Johns Hopkins research community access to its comprehensive research core facilities and resources for core development and management.
The portal, Core in a Box, was developed by a team of core facility experts and users from the Johns Hopkins University School of Medicine, Bloomberg School of Public Health, Krieger School of Arts and Sciences, and Whiting School of Engineering. It is designed for investigators and core facility personnel. Johns Hopkins schools are home to more than 120 core facilities designed to encourage and enable cutting-edge research in the areas of basic science, genetics, medicine and others. This site gives users access to all of these resources:
There are 2 different systems for ClinicalTrials.gov
- Public site: https://clinicaltrials.gov/
- User site: Protocol Registration and Results System (PRS) https://register.clinicaltrials.gov/
To create a ClinicalTrials.gov account or for help with registration or reporting contact:
- Oncology (SKCCC) Aliya Lalji (email@example.com)
- JHSPH – Miye Schakne (firstname.lastname@example.org)
- JohnsHopkinsU (SOM, SON) Oswald Tetteh (email@example.com)
JHM IRB Guidance: Registration of Clinical Trials on ClinicalTrials.gov
103.25 Organization Policy on Registration of Clinical Trials
You can access updated information on the Program’s Homepage
Power Point Presentation from the Office of Research Administration Presentation CDA AND MTA
SOM Office of Research Administration Information Page: http://www.hopkinsmedicine.org/Research/ora/agreements/index.html
BSPH Office of Research Administration:
School of Nursing Office of Research Administration: http://nursing.jhu.edu/faculty_research/research/administration/index.html
Homewood Research Projects Administration Information Page: http://web.jhu.edu/administration/provost/programs_services/research/JHURA
SOM ORA Sponsored Projects Handbook – Definitions of different types of agreements is very useful. Some other information is very dated. http://www.hopkinsmedicine.org/Research/ora/handbook/index.html
Office of Research Information Services (ORIS) – manages COEUS, which is used to route proposals through the JHU review process. http://prcoeus.johnshopkins.edu/orisite/oris_web/oris_index.html
For Questions about the Informed Consent Process contact the Research Participant Advocate Liz Martinez RN, BSN, CCRC at firstname.lastname@example.org
FAQ’s from HHS Website Regarding Informed Consent:
FDA Guide to Informed Consent:
JHMIRB Informed Consent Guidance:
JHMIRB Informed Consent Policy on Process and Documentation
JHMIRB Physician Consent Policy
Resource to Develop Consent Forms: Program for Readability in Science & Medicine (PRISM) https://www.grouphealthresearch.org/about-us/capabilities/research-communications/prism/
Johns Hopkins Research Administration Website:
Public Health Research Administration Website:
Homewood (Whiting, Krieger, Education) Research Administration Website:
Grant Proposal Resources from the Cancer Center Website (Also appropriate for non-onconology)
Coeus is the system that will convert research administration at Johns Hopkins from print to electronic and automated formats, fully integrated with the Federal Government’s single portal, https://www.grants.gov/
The Clinical Research Management System (CRMS) is an on-line tool that provides centralized, role-based access to information about studies and their participants. Administrators, financial specialists, and the study team use this information to help track their study and meet billing compliance requirements throughout the study. CRMS is linked to Epic for participant demographic data, and to the electronic Institutional Review Board (eIRB) for basic study information.
IRB CRMS Compliance Training: http://www.hopkinsmedicine.org/institutional_review_board/training_requirements/compliance_training.html
Dean’s CRMS requirement Update 6/11/2010: http://www.hopkinsmedicine.org/institutional_review_board/news/letters_dean/archive/crms_requirements_2010.html
Deans UPDATE to PRA Determination Criteria 4/2015
REDCap (Available to JHU Investigators via JHSPH Research Electronic Data Capture (DISC) http://www.jhsph.edu/research/centers-and-institutes/johns-hopkins-biostatistics-center/services
is a browser-based metadata-driven electronic data capture software solution and workflow methodology for designing clinical and translational research databases. It is widely used in the academic research community: the REDCap Consortium is a collaborative, international network of more than 250 institutional partners, with more than 20,000 total end-users employing the software more than 30,000 ongoing research studies.,
JHSPH RedCap contact Andre Hackman (email@example.com)
For protocols utilizing the services of the JH Clinical Research Unit (CRU), Scott Carey (firstname.lastname@example.org – 410.550.7198).
Link to REDCap website: http://www.project-redcap.org/
Bead Core (The BEAD Core provides consulting and support services to new and established investigators engaged in human subject research on the Bayview campus.
Sheridan Libraries JHUDMS: fosters data management best practices by providing guidance, education and training and offering data archiving and sharing services in support of researcher, institution, and agency goals.
Data Managers Interest Group:
What is a DSMP or DSMB? A Data Safety Monitoring Plan (DSMP) establishes the process for overseeing the progress of a human subjects research project or clinical trial. At JHU, all studies must provide a description of the DSMP. The JHM IRB will review the plan for appropriateness related to the design, risk profile, and study population for each study.
A DSMP’s purpose is to maximize research participant safety and welfare and data accuracy by periodically
- evaluating a study’s adherence to the IRB approved research plan, by affirming all study procedures are being followed;
- assuring compliance with applicable institutional policies and regulatory requirements, by ascertaining, for example, that informed consent is being effectively obtained and documented, or that all changes in research received IRB approval before initiation of any changes;
- confirming adverse events are properly identified, documented, reported, and resolved (if necessary);
- verifying the maintenance of accountability of the investigational product (i.e., drugs or devices); and
- examining data (and appropriate source documentation) for quality, validity, and consistency.
A DSMP designates who is responsible for the monitoring activity, while outlining when monitoring will occur (per established intervals), and what study documents and data will be reviewed. A critical component to the DSMP is that all detected deficiencies (i.e., “deviations”) are communicated to the Principal Investigator (PI) and study team for reconciliation, and for implementation of appropriate corrective action plans.
A Data Safety Monitoring Board (DSMB) is convened when an investigation’s design, risk profile, and/or study population warrants an independent review by a group of experts (e.g., a multicenter randomized trial of a high-risk new drug, or pursuant to NIH requirements). Per procedures outlined in the DSMP operational plan (i.e., “DSMB Charter”), the DSMB reviews data and safety information provided by an investigator. The DSMB assesses study progress via statistical analysis of interim study outcomes and safety signals, and then renders a decision that the study may proceed, be amended, or should cease enrollment. DSMBs will compile a summary report that, per JHM IRB requirements, are to be reported to the IRB.
SKCCC CRO Guidance:
Guidance for Data and Safety Monitoring Plans (ICTR DDRS):
DSMP/DSMB Consultation is provided by the JHU Office of Human Subjects Research Compliance Monitoring Program. Contact Fred Luthardt at email@example.com for additional information.
Please email our Research Navigators at ICTR_Navigators@jhmi.edu to access any of these templates.
FDA Guidance Document http://www.fda.gov/OHRMS/DOCKETS/98fr/01d-0489-gdl0003.pdf
Cancer Center’s DSMP provides helpful guidance on risk assessment, auditing and monitoring, and DSMBs http://cro.onc.jhmi.edu/pageData/dsmp.pdf
Guidance for Data and Safety Monitoring Plans (ICTR DDRS)
Please email our Research Navigators ICTR_Navigators@jhmi.edu to access any of these templates.
Epic In Research ICTR link: https://ictr.johnshopkins.edu/programs_resources/programs-resources/i2c/epic-for-research/.
Epic Training Portal: https://collaborate.johnshopkins.edu/sites/epictraining/
CRU Research Scheduling Tutorial Video:
Epic Order Sets for Inpatient Research:
If your research is to be conducted in an inpatient setting the IRB may REQUIRE that you develop an order set in EPIC to complete your research. You may also REQUEST that an order set be created to facilitate your research. Questions about order sets please email Pam Murray: firstname.lastname@example.org for assistance.
FDA Submissions Resources from the ICTR DDRS https://ictr.johnshopkins.edu/DDRS/
Please email our research navigators (ICTR_Navigators@jhmi.edu) to access any of these templates.
FDA Formal Meeting Request Guidance and Template
FDA Formal Meeting Request Blank Template
IND Exemption Request Guidance
IND Application Guidance and Template for Drug Products
IND Application Blank Template for Drug Products
IND Application Guidance Template for Biologic (Somatic Cell Therapy) Products
IND Application Blank Template for Biologic (Somatic Cell Therapy) Products
Letter of Authorization Guidance and Template for Drug Master Files
Letter of Authorization Guidance and Template for Investigational New Drug and Biologic Products
IND Annual Progress Report Guidance and Template Drug Products
IND Annual Progress Report Blank Template Drug Products
IND Protocol Amendments Guidance and Template for Drug Products
IND Protocol Amendments Blank Template for Drug Products
IND Information Amendments Guidance and Template for Drug Products
Protocol Development Guidance for Clinical Investigations Using FDA Regulated Drug Products
FDA Audit Preparation Resource and Checklist
Compassionate Use-Individual IND (Expanded Access) Guidance and Template
Withdrawal of IND Application for an Investigational Drug
IDE Application Guidance and Template for Significant Risk Devices
IDE Application Blank Template for Significant Risk Devices
Guidance and Template for Letters of Authorization to 510(k) or PMA
Device Study NSR vs. SR Risk Determination Request Guidance
Protocol Development Guidance for Clinical Investigations Using Investigational Devices
NSR Device Reporting Requirements
Device Accountability Log
IND Application Guidance and Template for Lawfully Marketed Botanical Products with No Known Safety Concerns
IND Application Guidance and Template for Unmarketed Botanical Products and Botanical Products with Known Safety Concerns
FDA Center for Devices and Radiologic Health (CDRH)
“CDRH Learn” Modules
FDA (Food and Drug Administration) Website Regarding GCP
ICH (International Council on Harmonization) Good Clinical Practice E6 Guidelines link
HHS (U.S. Department of Health and Human Services) HHS Policy and Guidance Website
GCP Lecture from Research Coordinator First Friday Series (audio and PowerPoint presentation)
SOCI GCP Lecture Series
Pharmacy and Investigational Drug Service (IDS) at The Johns Hopkins Hospital http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/pharm_jhh.html
IRB Organization Policy on Drug Use and Control in Clinical Investigations
Bayview Research Pharmacy Contacts:
Sasha (Aleksandra) Beselman, PharmD, MBA, CCRP (Research Pharmacist)
office (410) 550-2747
The Johns Hopkins IRB Policies/ Guidelines and Application Information can be found online at:
The Johns Hopkins School of Public Health IRB Policies/Guidelines and Application Information:
Johns Hopkins CareLink may be used to facilitate monitoring of Johns Hopkins research studies by study sponsors. It provides real-time web access for study monitors to review research study patients’ clinical data. Permission for this access requires coordination and communication between the study monitor and the Johns Hopkins research study team being monitored.
Discounted Research Participant Parking Information
Participant Payment Information- Email Mark Meyerer at Accounts Payable
JHMIRB Guideline Regarding Payments to Participants: http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/remuneration.html
The Research Participant Advocate Can Help with Participant Complaints or Issues
Liz Martinez 410-614-6323 or email@example.com
If you are preparing a literature search or looking for a publication related to your research, PubMed Central® (PMC) is a free, searchable archive of biomedical and life sciences journal literature at the NIH’s National Library of Medicine (NIH/NLM).
In an effort to synergize inter-disciplinary clinical and translational research, Johns Hopkins University (JHU) is committed to using innovative research tools and information technologies to promote collaboration regardless of organizational affiliation or position within the bench-to-bedside-to-population spectrum of science. This expertise portal is a key component of Johns Hopkins University (JHU)’s mission to catalyze the application of new knowledge and techniques to clinical practice at the front lines of patient care. http://www.experts.scival.com/jhuscopus/conceptSearch.asp?searchType=c
SOCI SOP Lectures
Please email our research navigators (ICTR_Navigators@jhmi.edu) to access any of these templates.
Available Templates Include:
Regulatory Records Checklist Template
Adverse Event Tracking Log Template
Delegation of Responsibilities and Signature Log Template
Financial Interest Disclosure Form Templates
Monitoring Visit Summary Log Templates
Regulatory Binder Protocol Deviation Log Template
Regulatory Binder Note to File Templates
Regulatory Binder Pointer Page Templates
Screening and Enrollment Log Template
Visitor Signature Log Template
Informed Consent Checklist Template
Participant Binder Protocol Deviation Log Template
Participant Binder Note to File Templates