OCR Newsletter: The Source Doc
OCR Newsletter: May 2018
PARALLEL REVIEW: You got your corporate funding – CONGRATULATIONS! You are eager to get started. But what’s next?
Everyone who secures funding knows that there is an administrative process to follow to obtain approval of the funding documents. Most companies require contracts for funding and contracts generally require negotiation. The single most important step to get your corporate contract moving is to seek Parallel Review of the funding contract. The parallel review process allows for the simultaneous negotiation of the contract, by CTCU, and budget, by the departmental Business Office.
To facilitate the contract and budget negotiation process for corporate-funded clinical trial agreements, the Clinical Trial Contracting Unit (“CTCU”) recommends that investigators have their Business Office request parallel review whenever feasible and as early as possible.
Investigators do not need to know the exact amount of support that a corporate sponsor is willing to provide before requesting parallel review. Once you are reasonably certain that the corporate sponsor is ready to proceed with both contract and budget negotiations, a parallel review request may be made. You also do not need to have initiated the Intuitional Review Board (“IRB”) submission prior to requesting parallel review.
The instructions are available in an eform in Penn ERA Proposal Development, Internal Documents, click Add Institution Forms/Supporting Documents:
· Open a proposal in Penn ERA;
· Upload the contract template in word format (or include an email from the Sponsor that it prefers to use the Penn template to begin negotiations);
· Upload the Protocol and the Informed Consent Form (both are preferred but only one is necessary; drafts are acceptable); and
· Add the Sponsor’s contact information to the form
· Send an email requesting parallel review to: firstname.lastname@example.org
Once the contract has been assigned to a CTCU negotiator, the investigator and other staff will receive an email advising who is assigned to the negotiation. CTCU keeps investigators and staff informed of developments as they occur. While CTCU negotiates the contract, the responsible departmental business office negotiates the budget. Once the budget is finalized, the business office completes the Penn ERA record and routes it for review and approval. The contract may be signed once the approvals have been confirmed via the Penn ERA routing.
Do I need to register my study on ClinicalTrials.gov Protocol Registration and Results System (PRS)?
This is a good question since there are differing and overlapping requirements by several organizations and regulatory bodies that determine if your clinical trial should be registered and results reported in the ClinicalTrials.gov Protocol Registration and Results System (PRS).
Generally speaking, the FDA requires registration on ClinicalTrials.gov of any interventional study of any FDA-regulated product (other than Phase 1 or small feasibility device studies). The FDA requirement applies to studies that have a connection to the U.S., specifically, a site in the U.S., an exemption provided by the FDA, or involve a product that is manufactured in the U.S. or its territories.
The NIH however, has a broader requirement for registration; for any NIH-funded research, NIH requires registration of any research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. There is no exception from the NIH registration requirement for Phase 1 or small feasibility device studies. Also, NIH requires registration of behavioral interventions.
As part of its requirement, NIH also specifies that a dissemination plan be submitted as part of the grant application. The dissemination plan is to ensure that the grant applicant will see that the clinical trial is registered and the results are reported in required timeframes and that the informed consent documents include a statement regarding the posting of clinical trial results on ClinicalTrials.gov. The dissemination plan also requires that the institution have an internal policy in place to ensure that ClinicalTrials.gov registration and reporting are done in compliance with ClinicalTrials.gov requirements. SOP 204 documents PSOM’s policy regarding compliance with these NIH requirements.
Publishing your results: Also of note, the International Committee of Medical Journal Editors (ICMJE) requires registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication. Registration on ClinicalTrials.gov is one way to satisfy the ICMJE requirement. The ICMJE requirement applies to any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. For those who are experienced with the PRS, you may want to check “What’s New” under the “Help” tab for the March 22 updates.
A new problem type has been added to the home page Record List and Custom Filter: Incomplete Results - per FDA Administration Amendments Act (FDAAA). This problem notice is issued when the All Results Expected date has passed and results information has not been posted to ClinicalTrials.gov for all Primary and Secondary Outcome Measures.
To request to open a ClinicalTrials.gov account of a trial or any related questions, email OCR’s CT.Gov email.
New! SOP 203: Statement of Investigator (Form 1572 and Investigator Agreement)
In general, if an individual is directly involved in the performance of procedures required by the protocol, and the collection of data, that person should be listed on the 1572. SOP 203 defines the responsibilities of Principal Investigators (PI) of clinical trials regarding completion of both:
· FDA’s Statement of Investigator (Form FDA 1572) for all investigational new drug studies (IND)
· Investigator Agreement for investigational devices (IDE) studies
SOP 203 will help your team decide who needs to be listed on the 1572. Both documents are also considered a Statement of Investigator. This SOP applies to all clinical investigations of drugs, biologics or devices requiring an IND or IDE within the Perelman School of Medicine (PSOM) for which a PSOM faculty member is the PI. Read the full Form 1572 SOP 203 or watch the eLearning module for FDA Form 1572.
ICH (International Council for Harmonisation) brings together regulatory authorities, researchers, and the pharmaceutical industry to achieve greater harmonization worldwide to ensure that safe, effective and high quality medicines are developed and registered in the most resource efficient manner. This is achieved through the development of various ICH Guidelines. The most referred to guideline is the ICH E6 for Good Clinical Practice (GCP).
Since the development of ICH E6(R1) in 1996, evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities. Advances in use of electronic data recording and reporting facilitate implementation of other approaches. For example, centralized monitoring can now offer a greater advantage, to a broader range of trials than is suggested in the original text. Therefore, the guidance has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting while continuing to ensure human subject protection and reliability of trial results. These updates include updating the standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency. The FDA implemented the revised ICH E6(R2) as GCP in March 2018.
All research teams, Investigators and Sponsors, at Penn should be familiar with the updated ICH E6(R2) guidance. Watch the eLearning Modules for GCP training that have been updated to include this new R2 information, or email OCR with any questions and further guidance regarding these changes.
Research Billing Update: A New Prospective Reimbursement Analysis Form is Available
A new and improved Prospective Reimbursement Analysis (PRA) form can be found on the OCR website. This form can be used for all study types and replaces the previous forms. If clinical items, tests or services will occur during the study, a Coverage Analysis must accompany the PRA form. A sample coverage analysis is provided as an example in the budget template tab within the PRA form.
The OCR- Finance team reviews the coverage analysis during the proposal review process to support study teams in navigating billing compliance. Please email OCR Finance for questions/comments. Your feedback is welcomed.
An Update From the Penn Human Research Protection Program: Current Perspective on the Implementation of the Revised Common Rule
We are all aware that there is a lot of discussion and possible confusion as to where the Revised Common Rule lives right now. After many years of public commentary and development, it was anticipated that the revised version of the Common Rule governing human subjects research would take effect on January 19, 2018. Subsequently, the Department of Health and Human Services (DHHS) released a notification that the revised Common Rule would be delayed, and not go into effect until July 19, 2018. The notice indicated that none of the components of the revised Common Rule could be implemented if they were contradictory to the currently approved version. This was a disappointing approach because revisions would have reduced burden for both researchers and the Institutional Review Board (IRB).
The Penn IRB is still working to reduce administrative burden of the IRB submission and review/approval process, while remaining compliant with the current version of the Common Rule. We have implemented updated letter templates no longer requiring signatures and mechanisms for improved document sharing with the Principal Investigator (PI) and their research team. We have streamlined our approach for research proposals qualifying for IRB exemption (meaning no additional submissions are required) and limiting the revisions requested for research qualifying as minimal risk, especially social/behavioral research.
There are elements to the new rule that that are not contradictory to the currently approved version and can be implemented now if the PI/study team wishes to do so, but this is not required. For example, sites could include the use of a one-page summary introduction document, introducing lengthy and complex informed consent forms. Or they could include new elements of informed consent related to future use of biospecimens and data. These elements and corresponding tools/guidance are available on the IRB website.
However, nothing is mandatory at this point. We will await further notification from the government related to implementation dates (it is also a likely scenario that the July date will pass and they will push this to January 2019) or if any revisions to the final rule as it was proposed are incorporated prior to it becoming the revised rule.
In an effort to build a robust infrastructure for supporting clinical trials, PSOM has invested in a comprehensive trial management system for Penn researchers. The Penn Clinical Trial Management System (PennCTMS) is designed to manage trials, track patients, and offers robust reporting capabilities.
The PennCTMS provides a range of research related functions to help manage clinical research and creates a centralized repository of the institution’s clinical research data. Available functions include:
· Tracking the status of studies allows departments to quickly identify the number of current trials recruiting or recently closed
· Subject tracking within PennCTMS helps study teams get accurate and up-to-date information for accrual goals
· Recording adverse events in this database makes the information accessible to Principal Investigators and compliance team members
· Studies created within PennCTMS can be synced with their counterpart PennChart research records, allowing patient information and statuses to flow bi-directionally between the two systems
· Patient schedule tracking
· Milestone calendars
· Electronic case report forms
Our goal is to work with research teams to implement PennCTMS in all departments and divisions within the Perelman School of Medicine in 2018. To date the PennCTMS team has onboarded 9 departments or divisions, including nearly 650 active research studies.
If you have questions about the system, or are interested in learning more about the onboarding process, please contact us about PennCTMS or refer to the website for more info on PennCTMS.
iConnect was adopted by the PSOM to increase clinical trial participation. People looking to participate in a clinical research trial can use iConnect to search a database of trials being conducted by Penn, and choose to contact the research site directly.
Various iConnect recruitment features that research teams can use are: Pre-screener eligibility, referral tracker, recruitment campaign tracker, website/flyer creation and mobile App creation. Watch a quick video on iConnect.
If your site is interested in having your clinical research trials added to the iConnect database, please contact OCR.
“I wanted you to be aware that our latest subject enrolled into our Stem Cell Trial was self-referred from iConnect. The patient, who is over age 75, found the system very user friendly. We really appreciate the immediate email notification of patient interest. I would highly recommend using iConnect for trials recruiting patients looking for an investigational treatment, especially those with long term chronic conditions.”
Karen Maslowski, RN, Clinical Research Nurse, Heart and Vascular Pavilion @ Presbyterian Hospital
Featured OCR Staff Member: Maha Dutt
Maha's educational background is in Biotechnology and Life Sciences, she has been part of the OCR family since 2014. As a specialist in the Operations unit, Maha helps assess educational needs, develop training programs and tools, as well as providing guidance to clinical research faculty and staff to aid clinical trial conduct. She works inter-departmentally and inter-institutionally to facilitate clinical research trials, and to facilitate decisions for the roll out clinical research infrastructure platforms, such as iConnect and PennChart.
Protecting the privacy and security of patient information is a top priority at Penn Medicine. Securely transmitting such information is a key component of this. Many of us are tempted to use email to transmit patient information, yet email is in many ways too risky for sending patient information, and should be avoided where possible. Some of the risks and safer alternatives are described here.
Some common pitfalls of using email to transmit patient information are:
· Email transmission outside of the UPHS environment is not secure.
· Email can easily be misdirected to unintended recipients, including to individuals who are unknown and may be untrustworthy.
· Email recipients meant to be kept confidential may be inadvertently “CC’d” rather than “BCC’d”.
· Emailing via “Reply All” may result in a disclosure of patient information beyond the minimum necessary individuals.
· Emailing patient information increases the exposure of patient information stored in email inboxes in the event of a phishing attack.
Email should never be used when transmitting large and/or sensitive patient data sets.
The following safer, alternate tools should be used to transmit patient information:
· Penn Medicine Remote Access Portal
· Penn Medicine network / shared drives
· Penn Medicine managed encrypted portable devices
· Penn Medicine secure file transfer services
· Penn Medicine approved third party services
Contact Penn Medicine IS for assistance in using these alternative ways to transmit patient information.
Continuing Education Opportunities:
For Credit Courses Open to Registration for Faculty/Staff: Summer 2018
REG 610 – Fundamentals of FDA Regulation (Thursdays, 4:00-7:00PM)
This introductory course provides an overview of regulatory affairs in relation to three key areas of development: Drugs, Biologics, and Medical Devices and examines the FDA guidance governing these products.
REG 611 – Clinical Study Management (Mondays and Wednesdays, 4:00-5:30PM)
This course focuses on the practical aspects of executing clinical trials in an academic environment in a GCP compliant fashion. Upon course completion, students will be able to effectively implement and manage clinical research studies. To see full course descriptions. For specific info contact Anna Greene.
Master of Regulatory Affairs (MRA) Degree
Join the Fall 2018 cohort of the Master of Regulatory Affairs (MRA) degree program offered through the Institute for Translation Medicine and Therapeutics at the Perelman School of Medicine at Penn! The MRA program prepares professionals to implement and comply with FDA regulations. The program is designed to create a culture of professionals who acquire the skills necessary to maximize compliance and minimize risk in the development of FDA-regulated products. Application Deadline: May 1, 2018. Learn more about the MRA degree. For specific info contact Anna Greene.
2018 CARE Awards
Penn Medicine annually recognizes the contributions of the clinical research community by supporting the CARE Awards. Three awards are presented to demonstrate an appreciation for the complexity of the clinical research field; The Rising Star, The Leading Edge and The Lifetime Achievement award. The awards will be presented to clinical research coordinators, nurses, or managers who best exemplify excellence in the knowledge, skills and values of the profession. The 2018 CARE Awards will be held in the BRB Auditorium on June 14, 2018 from 12pm - 3pm. Lunch will be served after the awards event.
For more information about the CARE awards or to nominate someone, visit SCRCM CARE Awards.
Break Zone: How Many Penn Abbreviations Do You Know?
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