Clinical Trials Office

Special instructions have been developed for research external reviewers accessing patient records in the Cerner Millenium PowerChart system.

See external reviewer instructions here

All requests for new ordersets or revisions to existing ordersets in PowerChart must be submitted via a ServiceNow form.

Submit CareConnect Service Request

With questions on this process, email the CareConnect team at careconnect@pennstatehealth.psu.edu.

In PowerChart, clinical trials information is documented and viewed in several places.

Information on how to view and modify clinical trials information, including adding an interdisciplinary narrative note and finding the clinical trials flag on the Alerts tab, and is available on Cerner Wiki.

See walkthrough of PowerChart documentation for clinical trials
(Cerner login required)

In PowerChart, eMessage Pools allow for a notification to be sent to a group of users who are part of a message pool. This is especially helpful when a research participant who is identified by the Alerts Tab has an OOS created for any ER visit, inpatient hospitalization or observation stay.

Admission notifications can only be sent to a message pool, not individual email accounts. Message pools can also be used for clinical staff to send messages to a research team.

Information on how to set up and use eMessage Pools can be found via the Cerner Wiki, including:

• Basic guide to direct messaging
• How to add contacts to the personal address book
• How to add or remove individuals from Pools

See all eMessaging guides on Cerner Wiki
(Cerner login required)

Other information on eMessaging can be found in the CareConnect Infonet section (internal access only; Penn State Health ePass login required).

Because of increasing concerns about cybersecurity and HIPAA, Penn State Health provides a Cerner tool that allows the organization to limit the visibility of external monitors/auditors coming to the site to review EMR data for participants enrolled in clinical trials.

In the Relationship Management Tool, study teams can create a patient list and assign that list to specific monitor(s); then, those monitors will only be able to see patients for that particular study and not have access to the entire EMR.

See how to use the Relationship Management Tool here

Penn State’s electronic regulatory (eRegulatory) system is Florence eBinders.

The purpose of the eRegulatory binder is to assist investigators and study teams with the electronic storage and organization of the regulatory documentation used in human-subject research for tracking and reviewing the implementation of clinical research protocols approved by the Institutional Review Board and Research Quality Assurance at Penn State College of Medicine.

The system is a flexible tool and can be utilized by single and multi-site studies and customized to meet the needs of a specific research protocol.

Each study is divided into multiple sections, each of which contains templates designed to help investigators achieve and maintain regulatory compliance and adhere to federal, institutional and Good Clinical Practice (GCP) guidelines for research involving human subjects.

Florence eBinders allows for previous paper-based files to exist exclusively in a digital format and provides remote access for startup, monitoring, and source data review for sponsors and CROs. Florence eBinders is complaint with 21 CFR 11 – electronic signatures, GCP, HIPAA and GDRP (Note: Penn State does not make general statements be in compliance with GDRP regulations as Penn State is not based in the European Union while its venders and contractor may make such compliance statements).

Per institutional policy CR406 – Use of Florence eBinders for Electronic Records, Penn State study teams will NOT upload any documents containing PHI to outside platforms as Florence eBinders provides a HIPAA-compliant environment for records. The only exception is for those documents that contain participant ID numbers, dates and research device serial numbers as their only PHI elements.

Monitors will be given read-only access with downloading privileges to Florence eBinders. Prior to getting access, monitors will be required to provide documentation of training. Those individuals who have not used Florence eBinders previously, or wish to take a refresher, can find training here.

For sponsors and CROs using Florence eBinders as their electronic trial master file (eTMF), file sharing has been enabled to allow for essentials documents to be shared from the site’s file to the eTMF.

Standardized Folder Structure

The Penn State instance of Florence eBinders has been standardized to optimize efficiency across studies regardless of sponsor, therapeutic area and study team by having standard folder structures and a standardized naming convention for documents. Standard folder structures ensure uniformity at the first layer of the study that can then be customized based on the individual study’s needs. The benefits of the standard folder structures:

• Organization: A standardized folder structure helps organize documents systematically, making it easy to categorize and locate files. This organization enhances overall efficiency and reduces the time spent searching for specific documents.
• Consistency: Consistent folder structures ensure that everyone within a team or organization follows the same framework. This consistency promotes a shared understanding of where different types of documents should be stored.
• Ease of Navigation: Users can navigate through the folder structure more easily when there’s a standardized layout. This reduces the learning curve for new team members and streamlines the document management process.
• Collaboration: Standardized folder structures facilitate collaboration by providing a common framework for sharing and accessing documents. Team members can work together more seamlessly when everyone is on the same page regarding where to find specific files.
• Version Control: A well-organized folder structure contributes to effective version control. Different versions of documents can be stored in a logical manner, reducing the risk of confusion and errors.
• Scalability: As the volume of documents grows, a standardized folder structure accommodates scalability. It allows for the addition of new folders or categories without disrupting the overall organization.
• Searchability: Standardized folder structures enhance searchability. Users can use the folder hierarchy as a guide to narrow down their search for specific documents, improving the overall retrieval process.
• Backup and Recovery: In case of data loss or system failures, a standardized folder structure facilitates backup and recovery processes. It ensures that critical documents are organized and can be restored more efficiently.
• Training and Onboarding: New team members can quickly understand the document storage system when there’s a standardized folder structure in place. This aids in the onboarding process and reduces the time needed for training.
• Security: A standardized folder structure supports better security practices. Access controls and permissions can be more effectively implemented when documents are organized in a logical and consistent manner.
• Compliance: In certain industries, compliance with regulations may require specific folder structures for document management. Standardization helps ensure that the organization meets regulatory requirements.
• Workflow Efficiency: The standardized folder structure contributes to overall workflow efficiency. Team members can collaborate, share, and retrieve documents more smoothly, leading to improved productivity.

Standard folder structures are available for drug studies, device studies, non-investigational product studies (e.g., registries, surgical intervention, etc.), and eTMF for Penn State investigator serving as the sponsor.

Standard Naming Convention

A standard document naming convention for documents offers many benefits:

• Consistency: It ensures uniformity in naming, making it easier for users to locate and identify documents. Consistent naming conventions reduce confusion and enhance overall organization.
• Searchability: Documents with standardized names are more easily searchable. Users can quickly find the information they need without wasting time on deciphering unclear or inconsistent file names.
• Version Control: A well-defined naming convention helps in version control. Users can easily distinguish between different versions of a document and track changes over time.
• Efficiency: Standardized naming conventions contribute to workflow efficiency. Team members can share and collaborate on documents seamlessly when everyone follows a consistent naming structure.
• Professionalism: Consistent and clear document names convey a sense of professionalism. It reflects positively on the organization and its commitment to organized information management.
• Reduced Errors: Ambiguous or non-standard document names can lead to errors, such as opening the wrong file. Standardized naming conventions minimize the risk of such mistakes.
• Compliance: With specific naming conventions, essentials documents can be more readily identified to demonstrate with regulations and GCP standards.
• Automation: Standardized naming conventions facilitate the implementation of automated processes, such as file sorting, categorization, and data extraction, leading to increased efficiency. Additionally, a standardized naming convention will support future integrations with Penn State’s IRB and clinical research management systems.
• Training and Onboarding: New team members can quickly adapt to document management practices when there’s a standardized naming convention in place. It simplifies the onboarding process.
• Communication: Clear and standardized document names improve communication within a team. It ensures that everyone understands the content and purpose of a document without ambiguity.

The current naming convention document can be found in the Central Documents binder in Florence or can be found on the Clinical Trials Office file repository. (Penn State Health login required).

The eRegulatory binder templates are for investigator-initiated trial use. Sponsored studies should follow sponsor guidelines for storage of regulatory materials.

A memo for sponsors and CROs can be found here (PDF download via Sharepoint).

For questions related to eRegulatory binders, email eRegulatory@pennstatehealth.psu.edu.

Get printable version in OneDrive
(Penn State Access ID login required)

Get printable version in OneDrive
(Penn State Access ID login required)

Clinical researchers have access to multiple Department of Health and Joint Commission-approved Penn State Health clinical spaces to conduct human research. In addition to clinical spaces, there are pre-approved, dedicated clinical research spaces also available. Clinical research policy CR-107: Clinical Research Locations has been created to list pre-approved clinical research locations on campus and outline the process by which an investigator or study team may request approval for an alternative location(s) to conduct a study.

The Clinical Trials Office (CTO) maintains a comprehensive list of all approved research locations on its website (see below). The list of approved locations in CR-107 will be updated biennially when this policy is reviewed to include any additional locations that are approved through the process outlined in this policy.

For most clinical researchers, these approved locations should provide adequate space to conduct their research; however, there may be nuances to the protocol or the patient population that would warrant the use of alternative locations. The process to request approval of alternative locations is outlined in CR-107 (located in on the Policy Manager) as well as below.

Current pre-approved, dedicated clinical research spaces

• Clinical Research Center*
• NMR Facility
• Penn State Exercise Research Center (HCAR)*
• Penn State Cancer Institute Exercise Unit (PSCI)
• Dermatology clinical research space (UPC II 2010/B)
• Neurology clinical research space (C2852/A, C3522, C5518, and H5508)
• Neuroscience clinical research space (East Campus 1302)
• Ophthalmology clinical research space (UPC I 501 A/B)
• Special Hematology (C6608)

* These spaces are supported and operated by Penn State Clinical and Translational Science Institute.

How to request an alternative location for a specific study

1. Principal Investigator (PI) obtains approval (letter, memo, email, etc.) either from the director that maintains oversight of the proposed alternative location, or the Operations Director of the Department which oversees the requested space.
2. PI submits director’s approval with a “Request for Use of an Alternative Research Location” form to the CTO by email (CTO@pennstatehealth.psu.edu) so that request can be reviewed by the appropriate parties.
3. Research Quality Assurance (RQA), CTO, and Facilities Management review the request. RQA will review the request to address biosafety matters if the study involves the collection, procession, and/or shipping of biospecimens. CTO will review the request to address billing compliance and clinical operation matters. Facilities Management will confirm that the proposed alternative location meets applicable regulations, including accessibility, privacy and space assignment.

Download alternative location request form

A Certificate of Confidentiality is a document issued by the FDA or NIH that:

• protects researchers and institutions from outside authorities collecting personally identifiable and sensitive information and
• permits researchers and institutions to refuse to disclose identifying information on research subjects in any civil, criminal, administrative, legislative or other proceeding (e.g., under subpoena, court order).

For questions about Certificates of Confidentiality, contact the Penn State Human Research Protections Program.

The clinical research guidebook was developed to provide a one-stop guide for faculty and staff members engaged in clinical research at Penn State College of Medicine/Penn State Health Milton S. Hershey Medical Center.

It has been adapted from the materials created and released by The Clinical Trials Resource Group at the University of California-Davis CTSC.

View the Guidebook

When the sponsor requires completion of a sponsor-provided checklist for validation of any Penn State Health/Penn State College of Medicine IT systems and resources, initiate the Request IS Service form and attach the checklist for completion.

Complete the Request IS Service form here (Penn State Health ePass login required)

Note: The Medicare Administrative Contractor (MAC) for Penn State Health/Penn State College of Medicine is Novitas Solutions Inc. As of July 1, 2013, the jurisdiction is designated as JL instead of J12. Currently, Novitas is requiring faxes (see template in OneDrive; Penn State Access ID login required) rather than mail communications.

Please see the CTO website for more information. (Penn State Health ePass login required).

Overview

The Centers for Medicare & Medicaid Services (CMS) have established regulations for coverage of device trials. These rules are found in the Code of Federal Regulations 42CFR 405.201 – 405.215 and 411.215 and 411.406. The study qualifies for Medicare coverage if the device trial meets the criteria in the regulations. In turn, this means routine costs during the qualifying device trial are covered. Even when a device is provided without charge, the MAC must still approve the study for routine costs to be billable.

Definitions

More information can be found on the Novitas Solutions website.

Investigational Device Exemption (IDE)

The FDA recognizes three regulatory classes of medical devices. For purposes of assisting CMS in determining Medicare coverage, the FDA will place all approved IDEs in one of two categories: Category A or Category B.

Investigational Device Categories: Medicare Coverage Principles

For IDEs approved by the FDA on or after Jan. 1, 2015, it will be the sponsor’s responsibility to submit to national CMS and provide Penn State Health with documentation. Penn State Health/Penn State College of Medicine will contact the Medicare Administrative Contractor via fax and receive and receive a confirmation acknowledgement in return.

Category A Device – Experimental

• These consist of novel, first-of-a-kind technologies. They are innovative FDA Class III devices for which the absolute risk of the device type has not been established and initial questions of safety and effectiveness have not been resolved. The FDA is unsure whether these device types can be safe and effective.
• Medicare covers the routine costs of clinical trials involving IDE Category A devices effective for routine costs incurred on or after Jan. 1, 2005.
• This extension of coverage only refers to the routine services performed for such a trial. The Category A device itself remains non-covered.
• See details on the Novitas website under Clinical Trials and Devices.

Category B Device – Non-Experimental/Investigational

• These devices are the newer generations of proven technologies that may be in FDA Class I, II or III. Initial questions of safety and effectiveness of these devices have been resolved, and the incremental risk of this device, generally an update to an existing device, is the primary risk in question.
• Medicare covers the routine costs of clinical trials involving IDE Category B devices effective for routine costs incurred on or after Jan. 1, 2005.
• Medicare covers Category B devices if they are considered reasonable and necessary, and if all other applicable Medicare coverage requirements are met.
• This policy does not infer that all devices classified in Category B will be covered under Medicare.

Coverage with Evidence Development (CED)

CMS provides for a coverage mechanism, referred to as coverage with evidence development (CED), in order to extend coverage for selected medical procedures, contingent upon the collection of additional data. In general, CED allows for coverage of FDA approved medical technologies and services when improvements in health outcomes have not been conclusively demonstrated. There are two types of CED:

• Coverage with appropriateness determination (CAD): The item or service is covered only when specific data are submitted in addition to claims data to demonstrate that the item or service was provided as specified in the NCD (database/registry).
• Coverage with study participation (CSP): The item or service is covered only after a formal National Coverage Determination request has been initiated and it is provided within a setting in which there is a pre-specified process for gathering additional data, and in which that process provides additional protections and safety measures for beneficiaries, such as those present in certain clinical trials (clinical research studies – expect to see an FDA approval letter with an associated IDE number). Sponsor is not required to show additional approval from CMS because it is already approved under the CED.

Humanitarian Device Exemption (HDE) and Humanitarian Use Device (HUD)

• A humanitarian use device (HUD) is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or manifest in less than 4,000 individuals in the United States per year.
• An approved HDE authorizes marketing of the HUD. However, the HUD may only be used after IRB approval has been obtained for the use of the device for the FDA-approved indication.
• The HUD may only be used in facilities that have an IRB and after the IRB has approved the use of the device to treat or diagnose the specific disease.
• Medicare covers HDEs if they are considered reasonable and necessary, and if all other applicable Medicare coverage requirements are fulfilled.
• No prior approval will be provided for these devices even if the patient is a participant in a clinical trial. MAC submission is no longer required. However, appropriate documentation, if requested, supporting the medical necessity of the procedure/device for the beneficiary must be made available upon request.

According to CDERs Division of Scientific Investigations, “records must be stored under conditions that will preserve their integrity, and that sites be able to retrieve and provide prompt access to such records if the FDA requests such records as part of an inspection”.

The Penn State Inactive Records Center was developed to provide such storage at low rates.

Contact the Inactive Records Center here.

Get copies of Inactive Records Center forms here.

For short-term storage of records on-site in Hershey, contact the College of Medicine Clinical Trials Office at cto@pennstatehealth.psu.edu.

Penn State College of Medicine’s digital systems have not had their compliance validated for electronic signature. When requested to provide assurance, investigators should use this statement:

“All persons granted access to the Penn State Health (PSH) electronic medical records (eMRs) undergo training in the operation and proper use of the system and are assigned specific access rights to system functions. Persons with signatory authority in the eMR have verified that their electronic signature is equivalent to their written signature (copy provided upon request). All employees of PSH and College of Medicine have been informed of and have agreed to abide by the standards of Penn State University and PSH with respect to privacy, confidentiality, security and dissemination of all electronic records and communications. At the present time we cannot assure that all of our systems are fully compliant with all provisions of 21CFR11. Nonetheless, FDA has stated in its Guidance for Industry: Electronic Source Data in Clinical Investigations that it does not intend to assess the compliance of eMRs with Part 11 (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-source-data-clinical-investigations).”

Study teams may be required to provide a certified copy of the electronic medical record in order to meet the requirements for the provision of source documents as per the Code of Federal Regulations and ICH Good Clinical Practice guidelines for patients enrolled in a clinical research study.

If this is necessary, a member of the study team should complete the form below and fax to the dedicated number listed on it.

Download a Word template of the request form from OneDrive; Penn State Access ID login required.

Most Sponsors and CROs offer translation services for consent documents, recruitment and participant materials. Penn State Health (PSH) also offers Interpreter and Translation Services for College of Medicine (COM) and PSH study teams when such services are not available through the Sponsor or COM/PSH investigators are the Sponsor. These services can be found on the PSH Infonet.

The Investigational Drug Service (IDS) at Penn State Health Milton S. Hershey Medical Center is charged with the control and management of investigational (research) drugs used in clinical (human) research trials throughout the institution.

See information about the Investigational Drug Service Pharmacy on the Pharmacy section of the Infonet (internal access only; Penn State Health ePass login required). Study teams may also print the Investigational Drug Service Information Sheet from OneDrive.

See all Investigational Drug Services policies in the Policy Portal (Penn State Health ePass login required).

For copies of current CV and licensure for Investigational Drug Services staff, please visit this link (in OneDrive; Penn State Health ePass login required).

Monitors must be granted Penn State Health ePass and CareConnect access.

For remote access: All monitors with existing accounts have remote access, and the instructions here have been updated to note how to request it for new monitors. All monitors must follow these instructions for setting up Duo two-factor authentication and logging on to the remote access portal before attempting to access the CareConnect software.

Requesting Access for Monitors/Sponsors

The Electronic IS Account Request Form (in ServiceNow; Penn State Health ePass login required) must be completed by the internal sponsor prior to account authorization being given. It may take two to three weeks for the access request to be processed, so study teams should plan accordingly.

Note: Before beginning this process, the on-site study team must gather certain information from the external monitor using the IS External Personal Information Form, available on the IS Infonet section (internal access only; Penn State Health ePass login required).

A guide to the specific use of the electronic account request form for monitor/sponsor access appears here; a general quick-reference guide and job aid for using the electronic account request form are available on the IS Infonet section (internal access only; Penn State Health ePass login required).

Request type: Choose “New/Change – PSH Staff or Non-Employee (contractor/vendor/student/faculty).”

Does the applicant have a current PSH/COM login (ePass)? Choose “No.”

Applicant personal information and address: Enter the contractor’s information.

Business info:

• For Employee Type, select “External Contractor/Vendor.”
• For Business Entity, select applicable organizational site.
• For Title/Job Description, type “Research Monitor/Auditor.”
• For Hiring Department, list the department requesting access.
• For Work Location, list the name of department requesting access and location where monitor/sponsor representative will be working from (e.g. Clinical Trials Office, SSB Room 200L, or “remote”).
• Provide questions and responses to two security questions.

PSU ID: Select “No.”

CareConnect:

• Check the box next to “CareConnect.”
• For Add/Change or Remove, select “Add/Change.”
• For Is This a Secondary CareConnect account, select “No.”
• For Position, select “Research External Reviewer.”

Business/Productivity:

• Check the box next to “Remote Access.”
• For Remote Access: Add/Change or Remove, select “Add.”
• For Remote Type, select “ClinicalRemote.”
• For Business Justification for Remote Access, write “Remote access utilizing Relationship Management Tool for clinical research monitors.”

Were you able to find all the items you needed to request access for? Choose “Yes.”

When finished, click “Submit” at right to submit the account request.

Cybersecurity and Privacy Training

The monitor/sponsor must complete Cybersecurity and Privacy training. Study teams should review Penn State Health Procedure CS-301 (in OneDrive; Penn State Access ID login required) and download and send the Substitute Training Instructions document (in OneDrive; Penn State Access ID login required) to external monitors. This details how they will complete this training.

Continued Authorization

Currently, account authorization will be audited approximately every three months. The person listed as the Manager/Supervisor/Chair on the form will receive a call from IT Account Management, who will verify that the individual still needs access, the anticipated date of completion, etc. Account Management will also be auditing records to be sure the individual accessed only the records they were supposed to.

On-Site Monitoring Space

There is monitoring space available in the Clinical Research Services area at the Support Services Building.

Email CTO@pennstatehealth.psu.edu to inquire about reserving space. It is never a good idea to have monitors working in study team workspaces or in open spaces throughout the institution.

On-Site Monitoring Guidelines

A document describing on-site monitoring guidelines is available to provide to monitors. Download the document from OneDrive (Penn State Access ID login required).

For clinical research study proposals that do not meet the criteria to be submitted to STAR, a specific process is to be followed during IAF creation in order to provide the appropriate information about the study to CTO and ORA.

See the clinical trial contract review process

Prior to protocol and budget review by the Clinical Trials Office, a Confidentiality Disclosure Agreement (CDA), also known as a Non-Disclosure Agreement (NDA), must be in place.

Learn more and submit a CDA

The Clinical Trials Office provides payer coverage analysis, which is a review of research-related documents to determine the Medicare billing status of both the study and the items/services provided to research subjects as part of a research study.

Please see the CTO website for more information. (Penn State Health ePass login required).

The coordinator worksheet requires study coordinators to complete only a personnel costs page when submitting a study in STAR.

Study teams should upload the coordinator worksheet to STAR before attending the budget/feasibility meeting. The worksheet can be uploaded using the “Upload Budget Documents” activity on the Budget Workspace (under the Internal Budget section). Once uploaded as COORDINATOR_WORKSHEET, the document will reside in the Budget Workspace under the Documents tab.

Download the Coordinator Worksheet

This patient care guidance chart is intended as a general guideline for use in determining which items and services should be budgeted as patient care costs on a grant application. In general, patient care costs are those services that are provided in the hospital or clinic setting.

This primarily pertains to federal and federal flow-through projects.

Please see the CTO website for more information. (Penn State Health ePass login required).

The following additional links provide a breakdown of startup budget considerations and guidance and resources for ongoing financial study management for clinical research.

• Office of Sponsored Programs fringe and F&A rate agreements
• Penn State Policy RA30 (Facilities and Administrative F&A Costs)
• Penn State Policy RA90 Finalization & Closure (formerly RAG 05 and RAG 08)
• Guidelines for financial management of industry-sponsored clinical trials
• Sponsor invoice template (available in OneDrive; Penn State Access ID login required)

Please see the CTO website for more information. (Penn State Health ePass login required).

Effective July 1, 2020, Penn State College of Medicine and Penn State Health have transitioned away from gift cards and checks for reimbursement/payment for clinical research participants. Greenphire ClinCards will replace all previous forms of reimbursement/payment.

See Greenphire information here

For details, contact the Controller’s Office (part of the College of Medicine Finance and Business team.

Please see the CTO website for more information. (Penn State Health ePass login required).

The CTO is required to budget all clinical research studies (regardless if the study meets the NIH definition of clinical trial) that is externally funded by a non-governmental agency. This applies to Investigator-Initiated Trials (IITs) and sponsored studies.

For proposals that do not meet the criteria to be submitted to STAR, investigators must submit an Internal Approval Form, or IAF, to the Office of Research Affairs. (This is generally used for industry-sponsored clinical trials.)

Learn more about the IAF process.

See IAF tips for clinical trials agreements.

The College of Medicine Business and Finance office also has a set of guidelines for the financial management of industry-sponsored clinical trials.

See financial management guidelines.

Penn State’s electronic regulatory (eRegulatory) system is Florence eBinders.

The purpose of the eRegulatory binder is to assist investigators and study teams with the electronic storage and organization of the regulatory documentation used in human-subject research for tracking and reviewing the implementation of clinical research protocols approved by the Institutional Review Board and Research Quality Assurance at Penn State College of Medicine.

The system is a flexible tool and can be utilized by single and multi-site studies and customized to meet the needs of a specific research protocol.

Each study is divided into multiple sections, each of which contains templates designed to help investigators achieve and maintain regulatory compliance and adhere to federal, institutional and Good Clinical Practice (GCP) guidelines for research involving human subjects.

Florence eBinders allows for previous paper-based files to exist exclusively in a digital format and provides remote access for startup, monitoring, and source data review for sponsors and CROs. Florence eBinders is complaint with 21 CFR 11 – electronic signatures, GCP, HIPAA and GDRP (Note: Penn State does not make general statements be in compliance with GDRP regulations as Penn State is not based in the European Union while its venders and contractor may make such compliance statements).

Per institutional policy CR406 – Use of Florence eBinders for Electronic Records, Penn State study teams will NOT upload any documents containing PHI to outside platforms as Florence eBinders provides a HIPAA-compliant environment for records. The only exception is for those documents that contain participant ID numbers, dates and research device serial numbers as their only PHI elements.

For sponsors and CROs using Florence eBinders as their electronic trial master file (eTMF), file sharing has been enabled to allow for essentials documents to be shared from the site’s file to the eTMF.

Standardized Folder Structure

The Penn State instance of Florence eBinders has been standardized to optimize efficiency across studies regardless of sponsor, therapeutic area and study team by having standard folder structures and a standardized naming convention for documents. Standard folder structures ensure uniformity at the first layer of the study that can then be customized based on the individual study’s needs. The benefits of the standard folder structures:

• Organization: A standardized folder structure helps organize documents systematically, making it easy to categorize and locate files. This organization enhances overall efficiency and reduces the time spent searching for specific documents.
• Consistency: Consistent folder structures ensure that everyone within a team or organization follows the same framework. This consistency promotes a shared understanding of where different types of documents should be stored.
• Ease of Navigation: Users can navigate through the folder structure more easily when there’s a standardized layout. This reduces the learning curve for new team members and streamlines the document management process.
• Collaboration: Standardized folder structures facilitate collaboration by providing a common framework for sharing and accessing documents. Team members can work together more seamlessly when everyone is on the same page regarding where to find specific files.
• Version Control: A well-organized folder structure contributes to effective version control. Different versions of documents can be stored in a logical manner, reducing the risk of confusion and errors.
• Scalability: As the volume of documents grows, a standardized folder structure accommodates scalability. It allows for the addition of new folders or categories without disrupting the overall organization.
• Searchability: Standardized folder structures enhance searchability. Users can use the folder hierarchy as a guide to narrow down their search for specific documents, improving the overall retrieval process.
• Backup and Recovery: In case of data loss or system failures, a standardized folder structure facilitates backup and recovery processes. It ensures that critical documents are organized and can be restored more efficiently.
• Training and Onboarding: New team members can quickly understand the document storage system when there’s a standardized folder structure in place. This aids in the onboarding process and reduces the time needed for training.
• Security: A standardized folder structure supports better security practices. Access controls and permissions can be more effectively implemented when documents are organized in a logical and consistent manner.
• Compliance: In certain industries, compliance with regulations may require specific folder structures for document management. Standardization helps ensure that the organization meets regulatory requirements.
• Workflow Efficiency: The standardized folder structure contributes to overall workflow efficiency. Team members can collaborate, share, and retrieve documents more smoothly, leading to improved productivity.

Standard folder structures are available for drug studies, device studies, non-investigational product studies (e.g., registries, surgical intervention, etc.), and eTMF for Penn State investigator serving as the sponsor.

Standard Naming Convention

A standard document naming convention for documents offers many benefits:

• Consistency: It ensures uniformity in naming, making it easier for users to locate and identify documents. Consistent naming conventions reduce confusion and enhance overall organization.
• Searchability: Documents with standardized names are more easily searchable. Users can quickly find the information they need without wasting time on deciphering unclear or inconsistent file names.
• Version Control: A well-defined naming convention helps in version control. Users can easily distinguish between different versions of a document and track changes over time.
• Efficiency: Standardized naming conventions contribute to workflow efficiency. Team members can share and collaborate on documents seamlessly when everyone follows a consistent naming structure.
• Professionalism: Consistent and clear document names convey a sense of professionalism. It reflects positively on the organization and its commitment to organized information management.
• Reduced Errors: Ambiguous or non-standard document names can lead to errors, such as opening the wrong file. Standardized naming conventions minimize the risk of such mistakes.
• Compliance: With specific naming conventions, essentials documents can be more readily identified to demonstrate with regulations and GCP standards.
• Automation: Standardized naming conventions facilitate the implementation of automated processes, such as file sorting, categorization, and data extraction, leading to increased efficiency. Additionally, a standardized naming convention will support future integrations with Penn State’s IRB and clinical research management systems.
• Training and Onboarding: New team members can quickly adapt to document management practices when there’s a standardized naming convention in place. It simplifies the onboarding process.
• Communication: Clear and standardized document names improve communication within a team. It ensures that everyone understands the content and purpose of a document without ambiguity.

The current naming convention document can be found in the Central Documents binder in Florence or can be found on the Clinical Trials Office file repository. (Penn State Health login required).

The eRegulatory binder templates are for investigator-initiated trial use. Sponsored studies should follow sponsor guidelines for storage of regulatory materials.

A memo for sponsors and CROs can be found here (PDF download via Sharepoint).

For questions related to eRegulatory binders, email eRegulatory@pennstatehealth.psu.edu.

Regulatory Binder Instructions

This guide is adapted from the Partners Human Research Quality Improvement Program and Enterprise Research Infrastructure and Services, in affiliation with Harvard Catalyst.

Purpose

A regulatory binder assists sites in achieving and maintaining regulatory compliance and ensuring the highest standards of human subject research. The binder also provides:

• Guidance for organization and record-keeping
• Assistance with proper study documentation and successful study management
• Access to additional information and online resources, such as IRB/HRPP policies, guidelines, forms and federal regulations

A set of regulatory binder dividers is available to assist investigator-initiated study teams who are creating their own binders.

Each binder divider outlines the regulatory requirements, institutional policies and GCP guidelines for organization and record-keeping that pertain to that section. The bottom of each binder tab includes QI tips, links to QI tools and references for applicable requirements.

General Guidance for Using a Regulatory Binder

• The regulatory binder should be established at the beginning of the study, prior to enrollment.
• Keep the regulatory binder current and up-to-date.
• Each team should identify the individual(s) responsible for maintaining the binder and ensure that this person is on file with the IRB as contact person to ensure that all IRB correspondence and documents are received/filed in a timely manner.
• Store binder in a safe and secure location, but accessible to study staff at all times. If sections of the binder are stored in a separate location (centrally filed) or maintained electronically, write a signed and dated note-to-file indicating the location and who maintains them. File the note behind the tab to which it applies.
• Subject-specific documentation and information (e.g., signed consent forms, test results and completed case report forms) should be maintained separately within the subject-specific binder/file.
• Customize the binder to meet the needs of the protocol. The sample tabs are a template. Teams should include only sections pertinent to their protocol, omitting unused sections and adding sections as needed. (See “Applicable sections” below for more information.) Teams unsure of what sections to include/exclude should contact Research Quality Assurance to clarify.

Applicable Sections

Depending on the nature of the research, some tabs may not be required. Use the list below to ensure that the applicable sections are maintained.

All studies

1. Protocol
2. Staff CVs
3. Staff licensures
4. Logs
5. IRB documents
6. Consent forms
7. Data collection/CRFs

Study-specific

8. Lab documents
9. NIH
10. Sponsor
11. Drug/device accountability
12. FDA
13. Financial disclosure
14. DSMB

Templates

All current documents can be found on the Florence website.

For questions about Florence, please email eRegulatory@pennstatehealth.psu.edu.

Updated lab certificates may also be found on the Infonet (Penn State Health ePass login required).

The success of a clinical research study depends on skilled coordination and collaboration among multiple disciplines.

Competent and well-trained clinical research personnel fulfill a central role in this process. To ensure that the research program at Penn State Health Milton S. Hershey Medical Center is of the highest quality, a competency-based orientation guide for clinical research personnel has been developed that is geared to novice and recently employed individuals at the medical center.

Based on the diverse locations and reporting responsibilities of research personnel at Penn State Health Milton S. Hershey Medical Center, this orientation material attempts to provide quality and consistency to orientation by focusing on a basic core body of knowledge.

New personnel complete this self-paced training under the guidance of an adviser. The training includes 13 essential competency areas and specific criteria necessary to achieve each competency.

The references provided in the competencies refer to both industry-sponsored and investigator-initiated research. The goal is to aid research personnel in understanding the regulatory requirements, as well as maintaining and promoting high ethical standards for the conduct of research.

Penn State College of Medicine and Penn State Health departments and programs are encouraged to adapt this material as necessary to meet specific programmatic needs, being sure to cite Maine Medical Center. Information from this manual may not be distributed for profit.

Competencies

• Core Competency 1: Good Clinical Practice Training
• Core Competency 2: Protocol Development/Evaluation
• Core Competency 3: Financial Management
• Core Competency 4: Clinical Trial Agreement/Grant Proposal
• Core Competency 5: Planning for Protocol Implementation
• Core Competency 6: IRB Communication
• Core Competency 7: Study Start-up
• Core Competency 8: Informed Consent Process
• Core Competency 9: Ongoing Conduct of Study
• Core Competency 10: Test Article Accountability
• Core Competency 11: Subject Safety/Adverse Events
• Core Competency 12: Document and Data Management
• Core Competency 13: Study Close-out

Competencies are currently under revision and will be posted when completed.

View research competencies on Penn State Health policy portal (ePass login)

The shipment of dangerous goods, including biological agents and materials, as well as dry ice, is heavily regulated by the federal government and the shipping industry, in particular the Department of Transportation and the International Air Transport Authority.

Strict requirements for packaging, labeling and completion of shipping documentation apply to many such materials shipped from Penn State Health/Penn State College of Medicine. As such, appropriate training in these aspects of dangerous goods shipping is required for any individual who offers these materials for shipment by ground or air transporters.

The training certification is good for two years if shipping by air, or three years for those who only ship by ground.

Complete mandatory Biological Materials and Dry Ice Shipping Training in COMPASS (Penn State Health ePass login required)

With questions on this training, call the Department of Safety at 717-531-7297.

A set of Standard Operating Procedures for Clinical Research describes the preparation and maintenance that the research team follows to ensure compliance with all FDA regulations and guidelines, and the policies and procedures of the College of Medicine and Penn State for all clinical trials conducted at Penn State.

View the Standard Operating Procedures in Policy Manager
(Penn State Health ePass login required)

Creation of forms and worksheets for research studies can be a time-consuming and costly activity. These forms and logs are provided for research personnel for use for investigator-initiated studies, or for industry-sponsored studies in which they are not provided by the sponsor.

These study management tools may be revised to fit the needs of study teams, keeping in mind that the goal is to maintain the integrity of the document to meet requirements by any auditing agencies and compliance to College of Medicine standards.

The Study Tracking and Analysis for Research (STAR) system is a comprehensive online tool designed to facilitate the submission, approval and management of select clinical research studies within Penn State Health Milton S. Hershey Medical Center and Penn State College of Medicine.

STAR is part of Penn State’s Centralized Application Tracking System (CATS) and is integrated with CATS IRB.

Learn more about STAR

Creation of forms and worksheets for research studies can be a time-consuming and costly activity. These forms and logs are provided for research personnel for use for investigator-initiated studies, or for industry-sponsored studies in which they are not provided by the sponsor.

These subject management tools may be revised to fit the needs of study teams, keeping in mind that the goal is to maintain the integrity of the document to meet requirements by any auditing agencies and compliance to College of Medicine standards.

To become a vendor to Penn State Health, the vendor representative(s) must be registered with GHX Vendormate Credentialing.

Study teams should not schedule meetings or introduce new products/services prior to the vendor being credentialed.

See details here

• Center for Medical Innovation
• Clinical and Translational Science Institute
• College of Medicine Business and Finance
• Institutional Review Board/Human Subjects Protection Office
• New Faculty Orientation – Researcher Requirements
• Office of Research Affairs
• Research Development
• Research Quality Assurance

• University Office for Research Protections
• University Office of Sponsored Programs

• Association for Clinical Research Professionals (ACRP)
• Society of Clinical Research Associates (SoCRA)