OnCore Clinical Trial Management System (CTMS) Minimum Standardized Requirements: School of Dentistry

OnCore Clinical Trial Management System (CTMS) Minimum Standardized Requirements: School of Dentistry OnCore CTMS Registration Requirements Main Tab Institution Tab Reviews Tab Status Tab Accrual Tab Version 2 12Feb2016 OnCore Version 14.0 This guide should be followed when entering and updating protocol information for research conducted within the School of Dentistry. OnCore Questions OnCore@iupui.edu Phone: 317-278-2600 OnCore Website https://oncore.indianactsi.org

OnCore CTMS Registration Requirements for Research at Indiana University and IU Health This document provides the necessary information to successfully onboard to OnCore and integrate with other IU and IU Health systems used in clinical research. Definitions Clinical Study: A research study using human subjects to evaluate biomedical or health-related outcomes. Prospective: Data collection starts with the present condition of a population of individuals and follows them into the future. OnCore Protocol Types- definitions from ClinicalTrial.gov : 1. Observational: Studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study. This may include Patient Registries. 2. Interventional: Studies in human beings in which individuals are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The individuals are then followed and biomedical and/or health outcomes are assessed. 3. Expanded Access (e.g. compassionate use): Records describing the procedure for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in a controlled clinical study. Expanded Access records are used to register all types of non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment IND, compassionate use, emergency use, continued access and parallel track. See flow diagram on following page: -2-

PC Console > Main > Details

PC Console > Main > Details>Protocol Details *Protocol No. The main identifier for a protocol. This needs to be a unique identifier for each protocol entered in OnCore. NCT number *Library *Department *Organizational Unit *Title Short Title *Age Formatting for identifier: Acronym for Primary Management-Group-Sponsor-PI-Short Title of Study OH-GSK-HARA-203111 for sponsored study OH-IIR-ZERO-EINSTEIN1 for investigator initiated protocol National Clinical Trial number found on https://clinicaltrials.gov/ Format example: NCT01956366. Field will not be available until other required fields are entered for this page and saved by hitting the Submit button. A library in Oncore determines the reference codes, forms, notifications and signoffs for a protocol. All protocols with an Organizational Unit of School of Dentistry must use a Library of Dentistry. Identifies the department OR department and division associated with the Principal Investigator of record at the IRB. Associated Department and Division for each PI can be located in the Admin > Staff Console. OnCore Support: OnCore@iupui.edu Organizational units are used to organize protocols into logical structural divisions, which is useful for reporting purposes and to restrict access to protocols. The organizational units available for selection are determined by the organizational units in your staff record. For Dentistry and Oral Health studies, the Organization Unit will be School of Dentistry. This field should always be verified before moving forward as it may autopopulate with incorrect information. Title is the full length title as listed on the protocol. This should match the title used in the KCIRB application. Please limit to 600 characters, if possible, to be consistent with ClinicalTrials.Gov field length. Short Title is an abbreviated version of the protocol title (i.e. sometimes the acronym for the study). Enter the age of the locally acceptable age group. Age is used to indicate the age group of the subjects that are eligible for this protocol, as listed in the protocol eligibility checklist. Based on NIH and NCI Definitions, select from one of the following categories: Children: Pediatric protocols where subject eligibility is 21 years of age and younger. Adults: Adult protocols where subject eligibility is 18 years of age and older. Both: Any protocols where the above age definitions overlap. IIR can be used instead of sponsor for investigator initiated research. This naming convention should be used by ALL protocols. Use when applicable not all protocols will have a NCT number. If you are unable to locate the PI s name in the Admin > Staff Console, contact OnCore support to add to the directory This field may autopopulate once the Library field is entered based on the privileges you are assigned. Studies including children will trigger the Consent at Age of Majority field to display Yes and prompt reconsenting of subjects once they reach 18. *Investigator Initiated Protocol Investigator Authored Protocols are studies that are authored or coauthored by an Indiana University/IU Health/Eskanazi/VA investigator regardless of sponsor/funding (federal, cooperative, consortium, industry). -5-

PC Console > Main > Details>Protocol Details Summary Accrual Info. Only This field is marked as 'Yes' when only summary subject data will be collected for a protocol. This enables the collection of subject accrual data summaries on the Accrual tab in PC Console, and disables individual patient registration. This setting cannot be changed once subjects are accrued to the protocol. Refer to page 20 for accrual entry guidelines. All School of Dentistry trials qualify for Summary Accrual Info only unless study procedures are being conducted at an IUH facility. *Protocol Type *Investigational Drug *Investigational Device Interventional Study (or Clinical Trial) :A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. Observational Study: A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study). Expanded Access: A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial. Investigational Drug field is answered as Yes if the protocol includes at least one investigational agent. An investigational agent is defined as having an IND number, regardless of the holder. Investigational Device field is answered as Yes if the protocol includes at least one investigational device. An investigational device is defined as having an IDE number, regardless of the holder. Protocol Type should match the Study Type listed on ClinicalTrials.gov. (If protocol is registered with ClinicalTrials.gov) -6-

PC Console > Main > Details>Accrual Information *Protocol Target Accrual Protocol Target Accrual is the total number of patients or participants needed for the entire study as stated in the protocol. This number displays in the top header of most screens within OnCore. This field is required for protocols that have set accrual goals. If the study is multi-site, this field represents the accrual goal for all sites. RC Accrual Goal (Lower) The RC Accrual Goal (Lower) is the minimum side of the range for the research center estimated total accrual. This might be the same as the RC Total Accrual Goal (Upper) listed below. The Low Accrual Report utilizes this field and can be used in an institutional metrics report to determine which protocols have met their accrual goals. The RC includes IU clinics and Oral Health as well as Methodist, University, Riley and Eskenazi hospitals. *RC Total Accrual Goal (Upper) *Accrual Duration (Months) RC (Research Center) Total Accrual Goal (Upper) is the maximum side of the range of the estimated total accrual for the institution (cannot exceed the IRB approved Accrual). Should be the number approved by the IRB for consented subjects Accrual Duration (Months) estimates the number of months the protocol may be accepting patients or participants to accrue. This number should match the accrual duration on the IRB application. This is informational-only field and does not drive any OnCore functionality. See protocol synopsis for estimate. PC Console > Main > Details>Completion Dates *Primary Completion Date The date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated. (Defined by ClinicalTrials.Gov). The RC includes IU clinics and Oral Health as well as Methodist, University, Riley and Eskenazi hospitals. This can be updated at the actual study close-out. -7-

PC Console > Main > Management -8-

PC Console > Main > Management>Management Details IRB No. The Institution Review Board (IRB) number used by the Indiana University Institutional Review Board to track the protocol. The number entered should match the syntax of the number in KC IRB - 10 characters consisting of all numeric characters. Copy, cut, and paste directly from KC IRB. If deferral is received form IU IRB to use a central IRB, enter the IU IRB deferral number. *ICRC Participation This will be no unless the study utilizes the adult and/or pediatric CTSI Clinical Research Center (CRC). If Yes, complete the 3 fields associated with ICRC participation: ICRC No., ICRC Approval Date, ICRC Category. Coding Scheme Internal Account No. Hospital Account No. The AE and SAE categorization that is being used for the study. If you are unsure of what to choose, MedDRA should be selected. Enter the IU funded internal account number. Enter the IUH vendor account billing number. Found on the IUH research grant form. If using another facility s account (ex. Eskenazi) this field can be used for both numbers This field is required for any protocol entering SAE data into OnCore or OnCore ecrfs. Not all studies will have this account no. Use as applicable Not all studies will have this account no. Use as applicable PC Console > Main > Management>Administrative Groups Management All studies will have a selected primary management group. The Group primary management group is determined by your individual department, division, or research group. If your area uses secondary management groups, select the secondary group/groups as appropriate for the study. Management Groups are used for reporting and access privileges. The Primary Management Group must be indicated by checking the associated box. Be sure to check the Primary Management Group even if there is only one Management Group listed. -9-

PC Console > Main > Staff PC Console > Main > Staff>Protocol Staff Role At a minimum: Principal Investigator: PI of record at the IRB. There will be only one principal investigator per study. Research Coordinator: non nurse coordinator Protocol Creator: This is automatically assigned to the initial creator of the protocol in OnCore (do not delete this role). Staff Name Other Commonly used staff: Co-Investigator: Other physicians acting/intervening with subjects. Research Nurse: RN/LPN coordinator Data Coordinator: Staff supporting OnCore entry (use if applicable in the research area) Study Site Contact: Primary coordinator for the study Select the staff member you want added to the protocol (this is a find-asyou-type field that pulls from all active staff records). A staff member may be listed multiple times with different roles on a single protocol. OnCore@iupui.edu If you cannot find a staff member, contact OnCore support and request the staff member to be added to the directory. -10-

PC Console > Main > Sponsor PC Console > Main > Sponsor>Sponsor Details Sponsor Details All sponsors associated with the protocol. Each study must have a principal sponsor indicated. This is done by checking the Principal Sponsor box next to the appropriate sponsor. The Primary sponsor is the primary organization that oversees the implementation of a study and is responsible for data analysis. If sponsor is not listed, contact OnCore Support to have added to the directory Always check the Principal Sponsor so it show up in the header. OnCore Support: OnCore@iupui.edu -11-

PC Console > Main > IND/IDE PC Console > Main > IND/IDE/Details *ID IND or IDE number assigned by the FDA. *Holder Type Select Industry if IND/IDE is held by a pharmaceutical company. Select Investigator if IND/IDE is held by IU/IUH Principal Investigator or other IU/IUH faculty. Select NIH if IND/IDE is held by the NIH. Select Organization if IND/IDE is held by an organization other than Industry, NCI or NIH. *Holder Name The holder of the IND/IDE. Often this is a PI name, study sponsor name or cooperative group name. -12-

PC Console > Main > ClinicalTrials.gov PC Console > Main > ClinicalTrials.gov PC Console > Main > ClinicalTrials.gov>Responsible Party Responsible Party This field is applicable for ClinicalTrials.gov studies only and refers to the Sponsor, Principal Investigator, or Sponsor-Investigator who is responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information This field should only be completed if applicable. Sponsor: the entity (e.g., corporation or agency) that initiates the study Principal Investigator: the individual who serves as the principal investigator and is designated as responsible party, consistent with the conditions described in the statute Sponsor-Investigator: the individual who both initiates and conducts the study -13-

PC Console > Institution PC Console > Institution PC Console > Institution>Participating Institutions Institution Represents the entity participating in a protocol. Indiana University (IU) must always be added to a new protocol. For system management reasons-indiana University(IU) currently includes University, Riley, Methodist, and Eskenazi hospitals as well as Oral Health and multiple clinic sites. Other IU Health hospitals are listed as separate institutions. If the institution you are searching for is not available, contact OnCore support staff for assistance. Additional research Institution and Study Sites listed here should correspond with sites listed in KCIRB. The Uses Research Center box should be checked for all research institutions using the IU IRB. Only enrolling institutions need to be added here. -14-

PC Console >Review >Update IRB Review -15-

PC Console > Reviews > Review Information Review Date The date of the IRB review was conducted. If this date is unknown, you may enter the IRB approval date. When using the Financials, this date can be used to trigger IRB invoiceables. Submit Date The date the submission is sent to the IRB. This date is located in KCIRB or other central IRB system. Review Reason The reason for the IRB submission. The following IRB review is required to be entered within OnCore at a minimum: Initial Review: Initial IRB submission Additional IRB reviews are optional. Review Type Action The type of IRB review will either be Full, Expedited, Exempt The IRB s decision regarding the submission reviewed. The following IRB Actions are common actions that will be used : Approved: Required in order for a protocol to be opened to accrual Additional Actions are available for tracking purposes. Action Date The date of the IRB s action. For new protocols that have been approved by the IRB, the Action Date = the protocol approval date. Expiration Date The date the current IRB approval expires. The expiration date of the review will automatically become the expiration date for any documents included in the details section of the review (e.g. Consent Documents). All Action dates are located in KCIRB or another IRB system. The expiration date is located in KCIRB or another central IRB system. Review No. The submission number for each review. Example: Enter NS for New Study,A001, A002, etc for amendments, R001, R002, etc. for continuing reviews. The review number should reflect the KCIRB review number or, if using an External IRB, follow the numbering system for the specific company- WIRB or CIRB. -16-

PC Console >Status >Protocol Status -17-

PC Console>Status> PC Console > Status>Protocol Status Status Statuses are assigned and unassigned in a predetermined order. Detailed definitions can be found below. OnCore statuses should be kept up to date so they accurately reflect the current status of the protocol. Status information will also be reflected in Cerner PowerTrials for qualifying trials. REQUIRED Status Types: Individual research groups may decide to utilize "Protocol Signoffs. See additional information in the IRB Initial Approval definitions. Open to Accrual Closed to Accrual Suspended On Hold Terminated IRB Study Closure Abandoned New: Status automatically assigned when a protocol is initially entered in OnCore. The current date is also assigned at this time, but may be edited. IRB Initial Approval: Status automatically populates into the Status tab when the IRB Approval is entered in the PC Console Reviews tab. Protocol Signoffs: After the 'IRB Initial Approval' status occurs, Protocol Signoffs (e.g. 'Central Admin Signoff', 'Account Signoff') may be required. These are determined by individual research groups and will not allow you to Open to Accrual until all signoffs are complete. Staff with appropriate access will be notified to complete these signoffs and will be the only staff members that can advance the protocol. On Hold: Trial has not yet opened to accrual and the PI or Sponsor has requested that all work on the trial stop until an issue, e.g. contract, funding, drug supply, etc. is resolved. Trial status may also be changed to On Hold if a protocol amendment requires IRB approval before a trial can open to accrual. A study can be placed on hold more than once during a trial s start-up period. Abandoned: Study has been withdrawn before it was IRB approved and no further action is expected. Open to Accrual: Status selected after the site has been opened to accrual/enrollment (all required reviews complete, sponsor authorization obtained, research group fully prepared to begin seeing patients). -18-

PC Console > Status>Protocol Status Suspended: Status selected after Open to Accrual to indicate that the protocol and subject accrual have been temporarily suspended. Once a trial has suspended, the user is given the option to undo suspend. The undo suspend option should only be used in cases that the trial was suspended by accident (i.e. clicked on the wrong button). Clicking undo suspend will erase the trial suspension from the status history. Closed to Accrual: Status selected when the protocol is no longer accruing/enrolling subjects. IRB Study Closure: Status selected to indicate that protocol ran its intended course (was not abandoned or terminated) and was closed with the IRB. This can also be used to indicate a study has expired and will not be reapproved. Terminated: Status selected to indicate that the protocol ended prior to completing the expected outcome and has been terminated with the IRB. It may also be used after the IRB study closure to indicate that no further action is required on the trial (i.e. financials reconciled). Date The date the status became active. This date may be retroactive, but future dates may not be entered. Initiator The initiator of the decision to activate the status listed. Required for the following statuses: On Hold Abandoned Suspended Closed to Accrual Terminated Reason The reason for activating the status listed. Required for the following statuses: On Hold Abandoned Suspended Closed to Accrual Terminated -19-

Summary Accrual Info. Only PC Console > Accrual -20-

This information displays only when the Summary Accrual Only field is marked as Yes for a protocol. It enables the collection of subject accrual data summaries on the Accrual Tab in the PC Console and disables individual subject registration. The setting cannot be changed once subjects are accrued to the protocol PC Console > Accrual>Add Protocol Accrual From Date to Through Date Date range for the accrual data being captured. Data should be captured by month (i.e. monthly - Jan 1 to Jan 31). This allows for flexible reporting. Start date should not be prior to the Open to Accrual Date. Thru Date should not exceed the Close to Accrual Date. Accrual Number of subjects accrued for the criteria defined (i.e. Age/Race/Sex/Ethnicity/Recruiter). To be consistent with IRB subject count authorization, it is recommended that a subject be counted as "accrued" once the subject has been consented. Institution Select the Institution that accrued the subject. This list should populate with a drop-down based on the Institutions entered under the PC Console > Institutions. Institution Type Identifies the Institution type (VA, Research Center, Affiliate, Consortium Member). This should populate based on the Institution selected PC Console > Annotation Annotations The annotations page is where protocol annotations are viewed and updated. Protocol Annotations are used to collect protocol data that is not accounted for by standard OnCore fields. Work with OnCore Support to develop specific annotations for your research group. -21-