Tools and Resources

resourcesThis page contains helpful resources on various research related topics.

Please click on the plus sign for details.

Clinical Departments Frequently Utilized in Research

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:

hopkinsmedicine.org/research/synergy/core-in-a-box/

Clinical Trials Registration

There are 2 different systems for ClinicalTrials.gov

To create a ClinicalTrials.gov account or for help with registration or reporting contact:

JHM IRB Guidance: Registration of Clinical Trials on ClinicalTrials.gov
http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/clinical_trials.html

103.25 Organization Policy on Registration of Clinical Trials

http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/organization_policies/103_25.html

You can access updated information on the Program’s Homepage

http://ictr.johnshopkins.edu/programs_resources/programs-resources/patient-safety-regulatory-complianceguidance/clinicaltrials-gov-program/

Confidential Disclosure Agreements and Material Transfer Agreements

Power Point Presentation from the Office of Research Administration Presentation CDA AND MTA
http://icn.onc.jhmi.edu/resources/cdamta.pptx

SOM Office of Research Administration Information Page: http://www.hopkinsmedicine.org/Research/ora/agreements/index.html 

BSPH Office of Research Administration:
http://www.jhsph.edu/offices-and-services/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

JHU Office of Technology Transfer (Inventions, Patents, Licensing agreements): http://www.techtransfer.jhu.edu/

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

Consent

For Questions about the Informed Consent Process contact the Research Participant Advocate Liz Martinez RN, BSN, CCRC at liz@jhmi.edu

FAQ’s from HHS Website Regarding Informed Consent:
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.html

FDA Guide to Informed Consent:
http://www.fda.gov/regulatoryinformation/guidances/ucm126431.htm

JHMIRB Informed Consent Guidance:
http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/informed_consent_i.html

JHMIRB Informed Consent Policy on Process and Documentation
http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/organization_policies/116_1.html

JHMIRB Physician Consent Policy
http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/organization_policies/111_14.html

Resource to Develop Consent Forms: Program for Readability in Science & Medicine (PRISM) https://www.grouphealthresearch.org/about-us/capabilities/research-communications/prism/

Contracts and Grants

Johns Hopkins Research Administration Website:
http://www.hopkinsmedicine.org/Research/ora/

Public Health Research Administration Website:
https://research.jhu.edu/jhura/

Nursing Administration:
http://nursing.jhu.edu/faculty_research/research/administration/

Homewood (Whiting, Krieger, Education) Research Administration Website:
https://research.jhu.edu/jhura/

Grant Proposal Resources from the Cancer Center Website (Also appropiate for non-onconology)
http://icn.onc.jhmi.edu/?section=grantResources

Coeus:
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/

https://research.jhu.edu/oris/

Clinical Research Management System (CRMS)

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

CRMS Wiki: http://crms-wiki.jhmi.edu/index.php/CRMS_in_the_Study_Lifecycle 

CRMS Overview: http://cro.onc.jhmi.edu/pageData/CRMS%20The%20Basics.%202013.09.pdf

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

Database and CRF Development

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 (ahackman@jhsph.edu)

For protocols utilizing the services of the JH Clinical Research Unit (CRU), Scott Carey (scarey@jhmi.edu410.550.7198).

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.

http://www.hopkinsmedicine.org/innovative/research/BEAD_Core/Index

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.

http://dmp.data.jhu.edu/

Data Managers Interest Group:

https://ictr.johnshopkins.edu/collaboration/collaborations/data-managers-interest-group/

Data Safety and Monitoring/ Data Safety Monitoring Boards

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.

JHM IRB Policy: https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/organization_policies/103_6c.html

FDA Guidance:
https://www.fda.gov/RegulatoryInformation/Guidances/ucm127069.htm

SKCCC CRO Guidance:
http://cro.onc.jhmi.edu/pageData/dsmp.pdf

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 Fed Ludthardt at fluthar1@jhmi.edu 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

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/

Epic Research Tips & Tricks: https://collaborate.johnshopkins.edu/sites/epictraining/_layouts/15/start.aspx#/Research%20Tips%20and%20Tricks/Forms/AllItems.aspx

Epic News: https://collaborate.johnshopkins.edu/sites/epictraining/news

CRU Research Scheduling Tutorial Video:
https://ictr.johnshopkins.edu/news_announce/demonstration-scheduling-a-cru-patient-using-epic-2012/

IRB Announcement: http://www.hopkinsmedicine.org/institutional_review_board/news/research_and_epic_april2013.html

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: pmurray@jhmi.edu for assistance.

FDA

FDA Audit FDA Audit Preparation Guidance and Checklist for Clinical Investigations Using FDA Regulated Drug Products

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)
http://www.fda.gov/MedicalDevices/default.htm

“CDRH Learn” Modules
http://www.fda.gov/Training/CDRHLearn/default.htm

Good Clinical Practice

FDA (Food and Drug Administration) Website Regarding GCP
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm

ICH (International Council on Harmonization) Good Clinical Practice E6 Guidelines link
http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html

HHS (U.S. Department of Health and Human Services) HHS Policy and Guidance Website
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

GCP Lecture from Research Coordinator First Friday Series (audio and PowerPoint presentation)
https://connect.johnshopkins.edu/p58ku50khjy/       

SOCI GCP Lecture Series

Section A: Scope of Clinical Research Download video or Watch video lecture

Section B: Regulatory History
Download video or Watch video lecture

Section C: ICH Good Clinical Practice Fundamentals
Download video or Watch video lecture

Section D: Impact of GCP and Future of GCP
Download video or Watch video lecture       

Investigational Drug Service

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
http://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/organization_policies/103_19a.html

Bayview Research Pharmacy Contacts:

Jim Monolakis, Pharm.D. (Investigational Drug Service Manager)
Pager: (410) 283-0327

Sasha (Aleksandra) Beselman, PharmD, MBA, CCRP (Research Pharmacist)
abeselm1@jhmi.edu
office (410) 550-2747

IRB (Institutional Review Board)

The Johns Hopkins IRB Policies/ Guidelines and Application Information can be found online at:
http://www.hopkinsmedicine.org/institutional_review_board/

The Johns Hopkins School of Public Health IRB Policies/Guidelines and Application Information:
http://www.jhsph.edu/offices-and-services/institutional-review-board/

Johns Hopkins CareLink

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.

https://www.hopkinsmedicine.org/CareLink/research-study-monitoring.html

Participant Complaints or Issues
PubMed

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).

http://www.ncbi.nlm.nih.gov/pubmed?holding=jhumlib&otool=jhumlib

SciVal (Find an Expert)

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

Technology Transfer (Reports of Inventions, Patents, Licensing, & MTAs
Templates (Documents for Regulatory and Participant Binders)

https://ictr.johnshopkins.edu/programs_resources/programs-resources/patient-safety-regulatory-complianceguidance/drug-and-device-resource-service-ddrs/drug-and-device-resources/template-documents-for-regulatory-and-participant-binders/

Please email our research navigators (ICTR_Navigators@jhmi.edu) to access any of these templates.

Available Templates Include:

Regulatory Binders

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

Participant Binders

Informed Consent Checklist Template

Participant Binder Protocol Deviation Log Template

Participant Binder Note to File Templates

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