Study Team Tools & Resources

Adverse Event Reporting Requirements Table

Adverse Events Log

Adverse Events and IND Safety Report Power Point 

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/

https://ictr.johnshopkins.edu/community/community/community-research-advisory-council/

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

For Questions about the Informed Consent Process contact the Research Participant Advocate Liz Martinez RN, BSN, CCRC at [email protected]

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/

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 appropriate 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/

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 Fred Luthardt at [email protected] for additional information.

Please email our Research Navigators at [email protected] 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 [email protected] to access any of these templates.