GWCC Protocol Creation Guidance - The GW Cancer Center

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ONCOREONCOREUSERS MANUALUSERS MANUALGWCCProtocol CreationGuidanceOnCore Clinical Trials Management System1

ONCOREONCOREUSERSUSERSMANUALMANUALProtocol Creation and SetupPC Console: CREATE A NEW PROTOCOLPurpose:This section covers setting up a new protocol.In This Section: Setting up basic protocol informationFurther Reference:For a comprehensive description of the material and contexts covered in this section, please refer tothe Protocol Administration Tutorial documentation on the online OnCore Learning Portal.2

ONCORE USERS MANUALSETTING UP BASIC PROTOCOL INFORMATIONFrom PC Console, select ‘New Protocol’ from vertical menu bar.The PC Console then opens a new screen for data entry.After entering the information on this screen, the user will hit submit and then be permitted to addinformation on the additional tabs across the top of the PC console page (management, staff, sponsor, IND/IDE,3

ONCORE USERS MANUALand clinicaltrials.gov). The following pages define each field of the PC console.PROTOCOL DETAILS (PC CONSOLE MAIN DETAILS TAB)Fields marked with an asterisk (*) are mandatory fields for all interventional cancer studies. All otherfields can be considered optional/informational fields that you can use at your discretion.OnCore FieldDefinition / InstructionsLibrary*Select ‘Oncology’Protocol No.*A unique, protocol identifier. This will be automatically generated.NCT Number*Enter the NCT ID from clinicaltrials.gov. Enter the entire number including the ‘NCT’. If the numberis pending, enter ‘TBD’. Please update the field once the number becomes available.Department*Select the department which is submitting the protocol. In general the department should reflectwho is managing the financial/contractual component of the study which may or may not be thePI’s home academic department.Organizational Unit*Select ‘Cancer Center’ if not pre-selected.Title*Full title of the protocol. This should match the official title noted within the ClinicalTrials.gov entryfor applicable studies.Short Title*An abbreviated version of the protocol title. When possible, Include the phase, drug ortreatment and disease. An attempt should be made to match the short title noted within theClinicalTrials.gov entry for applicable studies. This is the only title used on the NCI Data Table4 report.Objectives*The Objectives field is used to populate clinical trial listings on the public website and otherdocumentation. As a default, the ‘Purpose’ field on the clinicaltrials.gov listing should beused to populate this field. If the ClinicalTrials.gov listing is not available, a brief descriptionof the trial will be entered as an alternative. At a minimum, the primary study objectiveshould be included. This field should be reviewed carefully for word spacing and insertion ofextra lines. Please correct as needed.Phase*For Interventional studies acceptable phases include: pilot, feasibility, 0, I, II, III, IV, orcombinations such as I/II. For epidemiologic, cancer control/behavioral, observational, ancillary,correlative, or other biological studies, indicate ‘N/A.’Scope*Select local or national. Local protocols are only open at the cancer center or its affiliates.4

ONCORE USERS MANUALAge*Consent at Age ofMajority*Select the appropriate age category.Select ‘Yes’ if the protocol includes children and if these children will be required to re- consent onthor after their 18 birthday. Otherwise, select ‘No’.Drug Accountability*Select ‘Yes’ if drugs are being supplied by the study. Select ‘No’ if only standard ofcare/commercial supply drugs are used. Select ‘N/A’ if no drugs are used in the protocol.OnCore FieldDefinition / InstructionsInvestigator InitiatedProtocol? *Select ‘Yes’ if the protocol was written by a GWU investigator, regardless of sponsorship/fundingsource. Otherwise, select ‘No’.InvolvesTherapySelect ‘Yes’ if the protocol uses a therapeutic intervention (e.g. Treatment orSupportive Care study). Otherwise, select ‘No’.Exclude Protocol onWebCheck this box if the protocol SHOULD NOT appear in listings of available clinical trials (e.g.public website, published clinical trial listings, etc.). In general, all interventional trials shouldbe available on the web; however it may be appropriate to exclude others.Open for AffiliatesOnlySelect ‘Yes’ if the protocol will be opened for accrual at affiliate sites but not at the cancercenter. Otherwise, select ‘No’.Summary Accrual Info. Select ‘No’ when individual subjects will be registered to the protocol. ‘No’ must be selected forOnly*all interventional trials at a minimum. Select ‘Yes’ when only aggregate, summary subject datawill be collected for a protocol.Protocol Type*Select the appropriate protocol type from the list. Consult the CCSG data guide for specificdefinitions of each type. taGuidev3-508C.pdf)Basic Science (BAS): Protocol designed to examine the basic mechanisms of action (e.g., physiology,biomechanics) of an intervention.Diagnostic (DIA): Protocol designed to evaluate one of more interventions aimed at identifying adisease or health condition.Health Services Research (HSR): Protocol designed to evaluate the delivery, processes,management, organization, or financing of health care.Prevention (PRE): Protocol designed to assess one or more interventions aimed at preventing thedevelopment of a specific disease or health condition.Screening (SCR): Protocol designed to assess or examine methods of identifying a condition (or riskfactor for a condition) in people who are not yet known to have the condition (or risk factor).Supportive Care (SUP): Protocol designed to evaluate one or more interventions where the primaryintent is to maximize comfort, minimize side effects, or mitigate against a decline in theparticipant’s health or function. In general, supportive care interventions are not intended to cure adisease.Treatment (TRE): Protocol designed to evaluate one or more interventions for treating a disease,syndrome, or condition.Other (OTH): Not in other categories5

ONCORE USERS MANUALOnCore FieldDefinition / InstructionsCancer ControlSelect ‘Yes’ for protocols that are basic and applied research in the behavioral, social, andpopulation sciences to create or enhance interventions that, independently or in combinationwith biomedical approaches, reduce cancer risk, incidence, morbidity, and mortality. Otherwise,select ‘No’.Cancer PreventionSelect ‘Yes’ for protocols with interventions that keep a cancerous process from ever developingand may include health counseling and education, environmental controls, and product safety.Prevention also includes interventions leading to the discovery and control of cancerous orprecancerous processes while localized (eg. screening and early detection). Otherwise, select‘No’.Data Table 4 ReportType*Select the appropriate report type from the list. Consult the CCSG data guide for specificdefinitions of each type. taGuidev3508C.pdf)Registration Center*Select ‘Institution’ if GWU Cancer Center will be responsible for ClinicalTrials.gov registration andreporting. Otherwise select ‘Sponsor’ or ‘Other’ as applicable.InvolvesCorrelates orCompanionsSelect ‘Yes’ if this protocol will have designated companion studies in OnCore or if you will betracking correlative specimens for this protocol in OnCore. Otherwise, select ‘No’.Data Monitoring*Select the party responsible for monitoring the protocol data. All Phase III studies should haveDSMB oversight. GWU Cancer Center Interventional IITs will be monitored by the GWCC CTO ifthey do not have an external DSMP in place.AdjuvantSelect ‘Yes’ if study drug is enhancing or otherwise affecting the impact of another drug ortreatment.IncludesSpecimenBanking?Select ‘No’ here, as this refers to OnCore’s Biospecimen module, which we do not currentlyhave.GCRC (GWU CTSI-CNParticipation)Select ‘Yes’ if CTSI-CN resources are being used in the protocol. Otherwise, select ‘No’.Multi-site Trial*Select ‘Yes’ if this study recruits from two or more distinct study sites.For protocols in the Oncology library, this field affects Data Table 4 reporting as follows: If marked as 'Yes', the protocol is considered multi-site on the Data Table 4 report, regardlessof whether multiple institutions are listed in the PC Console Institution tab. If marked as 'No', the protocol is not considered multi-site on the Data Table 4 report,regardless of whether additional institutions are listed in the PC Console Institution tab. If left blank, the protocol is determined as multi-site based on whether more than oneinstitution is listed in the PC Console Institution tab.Investigational Drug*Select ‘Yes’ if an investigational drug is being used in the protocol. Otherwise, select ‘No’.6

ONCORE USERS MANUALPrecision TrialSelect ‘Yes’ for trials that incorporate biomarker defined targets and molecularly selectiveagents.InvestigationalDevice*Select ‘Yes’ if an investigational device is being used in the protocol. Otherwise, select ‘No’ or‘N/A.’OnCore FieldDefinition / InstructionsPrecision TrialClassificationBasket - for trials that allow the study of multiple molecular subpopulations of differenttumor or histologic types all within one study.Umbrella - for trials using a design that focuses on a single tumor type or histology.Targeted - for trials designed to evaluate treatments targeted at one or two molecularpopulations in single or multiple disease type.Other Adaptive Trials - for other studies believed to be precision medicine trials based on nontraditional study design not identified above, limited inclusion criteria, and emphasis on patientcentric treatment.Accrual InformationProtocol TargetAccrual*Enter the total number of subjects to be enrolled in the protocol at all sites.RC TotalAccrual Goal(Lower) *Enter the expected number of subjects to be enrolled at the Cancer Center. This number willinform PRMC initial and annual reviews.RC TotalAccrual Goal(Upper) *Enter the maximum number of subjects that may be enrolled at the Cancer Center. Thisnumber should account for consented screen failures at the Center.RC Annual AccrualGoal*Enter the expected number of subjects to be enrolled at the Cancer Center each year. This figureshould be based off of the CC Total Accrual Goal (Lower) and Accrual Duration.Affiliate Accrual GoalEnter the total expected number of accruals at all Cancer Center affiliates running theprotocol.AccrualDuration(Months)*Enter the estimated number of months it will take for enrollment to be completed for theprotocol.Completion DatesPrimary CompletionDateEnter the actual or estimated date that the final subject is examined or receives an interventionfor the purposes of final collection of data for the primary outcome. Refer to ClinicalTrials.govfor the anticipated Primary Completion Date.Study CompletionDateEnter the date on which data was (or is expected to be) collected. Refer toClinicalTrials.gov for the anticipated Study Completion Date.7

ONCORE USERS MANUALAfter entering these fields, click the [Submit] button and the protocol will be created and saved in thesystem.You now can enter data in the other tabs of the PC Console.PC CONSOLE MAIN MANAGEMENT TABENABLE PAYMENTS INTEGRATION:Select ‘Yes’ from the drop-down menu if you are planning to use the Forte Payment System to reimbursesubjects. Otherwise, select ‘No.’PROGRAM AREA*:Programs are defined by the individual cancer centers in which research takes place. This is a requiredfield for Data Table 4 reporting. The Program Area selection is driven by the Principal Investigator’saffiliation with a Cancer Center Program.1. Select the [Select] button to select a Program Area.2. Check the box next to the appropriate Program Area and then click the [Add] button. For PIs that arenot affiliated with a Cancer Center Program select ‘N/A’. If you do not know which program your PIis affiliated with, please contact the Cancer Center’s Clinical Research Applications Administrator forguidance (weberk@gwu.edu).ONCOLOGY GROUP*:Groups defined by the Cancer Center that define the patient population served by the studies.1. Select the [Select] button to select the Oncology Group(s).2. Check the box(es) for the appropriate Oncology Group(s) and then click the [Add] button.3. Once added, select which group is the Primary and then click the [Submit] button. For protocols thatserve more than one Oncology Group, select all included groups and note the Primary group.MANAGEMENT GROUP*:Groups within the Cancer Center that manage the protocols.1. Select the [Select] button to see the browse results for Management Group.2. Check the box next to the appropriate Management Group and then click the [Add] button.3. Once added, check the Primary checkbox and click the [Submit] button. AdditionalManagement Groups may be added as appropriate in the same way (only one group can bemarked Primary).8

ONCORE USERS MANUALPC CONSOLE MAIN PROTOCOL STAFF TAB*ADDING INDIVIDUAL STAFF TO A PROTOCOL1. Begin typing the staff member’s name in the Staff Name search box and select the hyperlink foryour choice.2. Select a staff role from the Role dropdown.3. Select the [Add] button.4. Repeat the above steps until all protocol staff members have been added.5. At a minimum, the PI, Submitter and Primary Study Coordinator or IRB Coordinator should beidentified.ADDING A STUDY TEAM TO A PROTOCOLYou can copy part or all of a study team from another study and add them to your protocol. This isuseful when the study staff are the same or similar across protocols.1. Select the [Select Team] button.2. Enter the Protocol Number or Sponsor Protocol Number in the Protocol No. field and select thehyperlink for your choice.3. Select the [Show Team] button.4. From the resulting staff list, check one or more staff members that you wish to add.5. Select the [Submit] button to add the selected staff to your protocol.WEBSITE CONTACT INFORMATION*To list a contact name on the cancer center website for a given study, that person must be identified onthe Protocol Staff list with a Role of ‘Study Site Contact’. This role assignment would be in addition totheir primary role on the study (if applicable).9

ONCORE USERS MANUALPC CONSOLE MAIN SPONSOR TAB*All sponsors must be listed in the Sponsor section. This includes any organization that provides drugs,funding, NCI credits or other support for the study. Studies where GWU is the responsible partyshould always have GWU noted as the primary sponsor.1. Click the [Add Sponsor] button to see the browse results for Sponsors.2. Select a sponsor for the study from the dropdown menu.3. Select the blue [Add] link to add the sponsor. Repeat steps 1-3 for each sponsor associated with theprotocol.4. Once the sponsor has been added, record the Sponsor Protocol No. (aka. Sponsor protocol ID)and select the ‘Principal’ checkbox next to the study’s principal sponsor. For protocols thatmeet the criteria to be included on the NCI Data Table 4 Report, the Principal Sponsorindicator will be used to determine the sponsor number to use on the report. At least onesponsor must be marked as the Principal Sponsor for the protocol to be included in the report.If more than one sponsor is marked as Principal, a warning message will appear upon clickingSubmit, indicating potential problems with NCI Data Table 4 accrual reporting.5. The specific name of the financial sponsor for the clinical research study must also be noted ifdifferent from the Principal Sponsor. To designate the funding source add the sponsor andselect the [Edit] link under the Role(s) column. There you will be able to check ‘FundingSource’. Note that funding source does not indicate which group is providing payment to thesite but rather which group’s funds are being used to support the trial.6.Other roles such as ‘Agent Source’, ‘Clinical Research Organization (CRO)’, ‘Data Analysis’, and‘Design’ should also be assigned to each sponsor as applicable, using the [Edit] link under the Rolescolumn.7. Select the [Save] button to save your selections.PC CONSOLE MAIN IND/IDE TABPlease leave this area blank at the first stages of protocol entry into the system. Once this information isavailable it should be entered into this tab.IND/IDE INFORMATION1. Select ‘Yes’, ‘No’ or ‘N/A’ from the Investigational Drug and Device dropdowns and select theappropriate responses.2. If ‘Yes’ is selected, select the [Add] button on the Details block.3. Enter the ID, Holder Type, Holder Name and any other relevant details and then select the ‘Save’hyperlink.10

ONCORE USERS MANUALPC CONSOLE TREATMENT DISEASE/DIAGNOSIS TABTo be filled out after the budget and contract have been finalized. If you are a coordinator, pleaseignore the Treatment tab; filling in the information too soon can conflict with the calendar importprocess.Disease Sites are used to identify the disease types that are allowed by your protocol. These diseasesites are defined by the NCI and cannot be changed. If you are authorized to fill in this tab, choose alldisease sites included by the study’s eligibility criteria.1. Click the [Select] button to see the browse results for Disease Sites.2. Check the boxes next to the Disease Sites for your protocol and then click the [Add] button.3. Repeat this process until all applicable disease sites have been added.PC CONSOLE INSTITUTION *Identify all study sites and study locations for the protocol.ADD THE CANCER CENTER INSTITUTION1. Click the [Add] button to see the browse results for Institutions.2. Select the checkbox for the ‘GW Cancer Center’.3. Select the [Save] button to add the institution to the protocol.4. By default, all Study Sites will be selected under the ‘Institutions’ column. De-select anyStudy Sites not participating in the protocol.5. Select the [Submit] button to save your selections.SELECT PARTICIPATING STUDY SITES1. Using the same steps as above, use the [Add] button to add additional sites which areparticipating as affiliates or as sub-sites to the George Washington Research Institute.2. Select the [Save] button to add the additional institution(s) to the protocol.3.Update the list of Study Sites for each institution and select the [Submit] button to saveyour selections.11

ONCORE USERS MANUALPC CONSOLE DOCUMENTS/INFO *The Documents/Info section can be used to add relevant protocol documents for review by the PRMCand for access by protocol staff. These documents can include PRMC submission documents, protocols,investigational brochures, eligibility documents, etc. Please refer to the PRMC submission form todetermine which documents should be uploaded for your study.ADDING AN ATTACHMENT1. Select the [Add] button.2. Choose the appropriate document type from the Document Type dropdown menu.3. Enter the document Description, Version Date, and Expiration Date in the appropriate fields.4. Click the blue [File] link and then select the [Choose File] button to locate the file on your localcomputer or network hard drive.5. Select the [Add] button to attach the document to the study.6. Repeat steps 1 – 4 above to add additional documents.12

ONCORE USERS MANUALADDITIONAL SUBMISSION DETAILSThe following details are required before a study can be submitted for PRMC review, so be sure that you havefilled them in:1. PC CONSOLE MAIN DETAILS: Investigational Device. Select ‘Yes’ if the protocol involves an IDEdevice, ‘No’ if it does not involve an approved device, or N/A if it is not applicable.2. PC CONSOLE MAIN MANAGEMENT : Priority Score. Insert the 1-5 score as outlined on the PRMCsubmission form.3. PC CONSOLE MAIN SPONSOR: Select [Edit] next to each sponsor to clarify their role in the project.DATA TABLE 4 REPORT SETTINGThe Principal Sponsor's default Sponsor Type may be overridden for users with the appropriateprivilege. The override is applied only for this protocol and will change the way the p

Protocol Creation Guidance OnCore Clinical Trials Management System . ONCORE USERS MANUAL 2 ONCORE USERS MANUAL Protocol Creation and Setup PC Console: CREATE A NEW PROTOCOL Purpose: This section covers setting up a new protocol. In This Section: Setting up basic protocol information

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