Introduction to SureSource

Transcription

1 Multifunctionality Multifunctionality Form Are there any changes in health to be reported? Are there any changes in concomitant medications to be reported? Please update the Concomitant Medication Log as applicable. Prohibited Concomitant Therapies and Drugs Urine sample was collected on: Urine sample was Time of collected at: Results: Negative: Positive: Urine pregnancy test was performed by: Exportable comments::(200 character limit): tes: site # 01 / supply ^ 00:00:00 FFF- DEM01008 Switch User Visit List Med Hx AE ConMed Supply Multifunctio Prohibited Concomitant Therapies and Drugs Logged in : Charlie Beitz Coodinator Per the exclusion criteria,subjects must not use prescription or over the counter medication for the purpose during the study. of treating sleep distrubance,within 14 days before dosing. Subjects are not permitted to use sleep aids - EIAEDs: Use of carbamazepine,oxcarbazepine,phenytoin, and presumed EIAED eslicarbazepine Other concomitant medications may be allowed at the discretion of the PrincipalInvestigatior or discussed Transcrib with the Medical Monitor,as appropraite. Refer to the Fycompa Package Insert for additional information associated with the following drug interactions: - Contraceptives: A 12-mg QD dose of perampanel may decrease the effectiveness of hormonal contraceptives containing levonorgestrel. - Alchohol and other CNS: depressants :The concomitant use of perampanel and CNS depressants (eg, benzodiazepines,narcotics,barbiturates,sedating antihistamines )including alcohol may increase CNS depression. assessment: Urine pregnancy test was reviewed by: Initials Initials 1-7 AE and ConMed Review & Urin V (Last Updated 2/Feb/201 Close SureSource Site Dashboard Review Dashboard Audit Dashboard Administration Clinical Mr. Edward Seguine Manage Studies All Manage Studies Copy CSV Print Search: Screening Number: DEMO1008 Study Sites All Enrolled Signed Unsigned All Partial Complete All Complete Open Closed All Serious: Unassessed: Adverse Events and Concomitant Medications Review LCQ LCQ Clone LHW QA Baseline Showing 1to 4 of 4 entries equivalent, after 13;00(1 pm) on PSG visits. In addition to the prohibited concomitant medications described below subjects should avoid caffeine, or its The following are also prohibited as concomitant medications: - Strong CYP3A inducers other than AEDs (eg,rifampin,st. John s Wort) Introduction to SureSource keep the pen. not the paper.

2 CONTENTS OVERVIEW SITE BENEFITS SURESOURCE TABLET SURESOURCE PORTAL SURESOURCE FAQs CONTACT 12 2

3 OVERVIEW FACT: The first purpose-built esource solution, Clinical Ink s SureSource was developed by an experienced PI to ease the burden of clinical research for site users. Clinical Ink s SureSource technology is the most widely used electronic source (esource) platform that streamlines clinical development by replacing inefficient paper source and CRFs with intuitively-designed electronic source (esource) forms that capture data directly via tablet. Unlike EDC, SureSource is designed to mimic typical site workflows while permitting data to be captured and validated electronically at the point of care during the actual subject visit. Because data is captured and validated electronically, source document verification (SDV) is eliminated, data queries are significantly reduced and remote, online monitoring can occur in real-time reducing the burden on both sites and monitors. SITE BENEFITS By making clinical research easier for site users, SureSource improves clinical trial efficiency, quality and safety. Designed to work completely offline to directly capture esource data and documents, SureSource eliminates the time-consuming manual activities and potential errors required with traditional paperbased data capture. Convenient Online Training A convenient web-based training program available anytime and from anywhere, SureSource University provides individual training to ensure complete familiarity with the SureSource platform. Following the web-based training, sites will require hands-on practice completing forms to ensure confidence when used with patients. 3

4 Familiar Look and Feel Specifically built as a tablet-based application that mimics the familiar paper-pen interface, SureSource was designed to look and feel just like familiar paper source. As such, each esource form can be fully customized and configured according to specific study protocol. Site-Centric Design Specifically designed to address the workflow needs of research sites, SureSource features a simple, elegant user interface that mirrors the natural workflow of sites maximizing efficiency, quality and speed. Ideal for users with any level of research experience, SureSource guides proper protocol execution while automatically validating data upon entry. Eliminates SDV As electronic data is initially captured during the patient visit, SureSource produces only one data set to completely eliminate time-consuming SDV. Enables Remote Monitoring The secure web-based SureSource portal provides remote access to source documents and data, providing a full context of study information that speeds reporting of potential safety concerns and allows clarifications to be made without having to travel to the site. Regulatory Compliant SureSource ensures ALCOA data and provides sites with a complete regulatory-compliant electronic audit trail at study close for convenient storage and access. FACT: SureSource is used in more clinical studies than any other esource solution currently available. 4

5 SURESOURCE TABLET Built as a tablet-based application that mimics the familiar paperpen interface, SureSource was designed to look and feel just like familiar paper source. As such, each esource form can be fully customized and configured according to specific study protocol. Visit List Med Hx AI ConMed Supply SUBJECT S VISIT LIST CONNECTED Randomization#: Status: Screened Subject Add Form Dispaly Visit List? Refresh Expand All Collapse All Randomization Status Visit Form Eligibility Criteria Form Download Open Add Form: Allows user to create new patient form Randomization Form Download Open Status Multifunctionality Visit Form Multifunctionality Form Download Open Status Buttons: Displays current document status; complete/partially Post Dose Procedures Form RAVLT Assessment Form Download Download Open Open Source Icons: Indicates original source data classification (i.e. paper) Translation Status Visit Form NTB Visual Paired Association Only Download Open Subject Chart View The Subject s Visit List displays all forms currently created for each patient. 5

6 EST Switch User Logged in: Ed Seguine Coordinator Visit List Med Hx AI ConMed Other Serious Adve... Visit 2 Site # 01 Screening: Visit: Visit 2 I have verifies that this is the correct chart Visit Information Visit date 0 7 J U L Required Fields: Yellow highlighted areas indicate required fields; conditional logic Informed Consent Is a new version of the Informed Consent available? Was a new version of the Informed Consent signed by the subjet? Version Date Was the subject given adequate time to read the Informed Consent and to have his/her questions answered prior to signing the form? Required: IC version date. Must be: 5 visit date y: Guide Text: Ensures proper protocol execution Signed on Was Informed Consent signed prior to any study procedures being performed? Was a signed copy of the Informed Consent given to the subject for his/her records? at Handwritten Ink tes: Capture ad-hoc notes electronically Is a new version of the Informed Assent available? Was the subject given adequate time to read the Informed Consent and to have his/her questions addressed prior to signing the form? Was Informed Assent discussed with subject? If yes, by: Version visit Info & Informed consent - Page 1 Date IC cont., AE, ConMed, & Eligibility criteria review - Page 2 Asthma control - Page 3 Signed Asthma exacerbation history - Page 4 on Asthma exacerbation history 2 - Page 4 at: Asthma exacerbation history 3 - Page 4 Vital signs - Page 7 cedure being performed? Physical exam - Page 8 Physical exam 2 - Page 9 Physical exam 3 - Page 10 the subject for his/her records? Physical exam 4 - Page 11 Physical exam 5 - Page 12 Urine preg. test & ediary training and disp. - Page 13 Randomization - Page 16 d visit to report? Randomization cont - Page 16 Study drug - Page 16 V n III Unnnmd Vnmmmd Study drug cont - Page 16 Rescue medication (SABA) & Next visit info..page 18 Protocol # CPOR General notes - Page 19 General notes cont. - Page 20 Visit info & informed comment V1485 (Last Updated) 15Jun2014 Close Jump-To Page Navigation: Ensures proper protocol execution Handwriting Recognition Fields: Powerful technology captures handwriting for predefined fields

7 << SURESOURCE PORTAL Remote Document Review Once data is captured and uploaded, the SureSource platform provides real-time, remote access to source documents and data. The SureSource portal is an interactive web-based portal that enables sites, sponsors, monitors, CROs and other third parties to remotely monitor and review a study. Designed to replicate the on-site monitoring experience, dynamic dashboards allow monitors to identify open/ closed queries, manage adverse events, and track subject completion status. Dynamic Document View: View and print source documents with notes Site Dashboard Review Dashboard Audit Dashboard << Page 5 site: 2 Screening Visit: Screening Visit Query History Validations Drugs of Abuse Screen Kit expiration date: 3 1 JUL Kit batch number: 20 at Drug screen data collected by tes : Overridden Validation Rule: Highlights a required field left blank 7

8 << SureSource Site Dashboard Review Dashboard Audit Dashboard Clinical Test Monitor Manage Studies vartis Plot Manage Subjects Complete Subject Chart 022 Chart Screening#: 022 Randomization #: Subject Status: Completed Site : Development << Previous Chart Next Chart Visit MedHx AE ConMed Other Lab Queries Audit Sign Chart Signed Brian Olson Date: 12-Jan :44 Comments: comment View Signature Form Status Form # Visit Form Visit Date Last Modified Date Last Modified By Reason Incomplete Open Queries Search: 1 Screening visit 02-Apr Dec-2012 Test coordinator To be completed at a later date 0 2 Period 1: Day 1 12-Apr Dec-2012 Test coordinator To be completed at a later date 0 P 3 Baseline: Day Apr Dec-2012 Brian Olson To be completed at a later date 3 4 Eligibility Criteria 01-Apr Jan-2012 Brian Olson To be completed at a later date 0 One-Click Metrics Dashboards View study data at Study, Site, Subject and Form level 8

9 SURESOURCE FAQs Q: How does SureSource work? Every SureSource study is comprised of five phases designed to streamline clinical development, from Start to Submit. During study Start, sponsors work with Clinical Ink to develop electronic forms (esource) used by sites to capture study data. From there, site users Capture data electronically during the subject visit using a tablet-based application. Intuitively-designed esource forms reflect the clinical workflow and look just like traditional paper source, but incorporate all CRF data fields and edit checks. To further streamline development, some studies will Connect with many common supporting technologies (i.e. IVRS, CTMS, device integrations) for advanced features including audio file uploads, push-button randomization and automated SAE notifications. To Manage studies, sponsors/ CROs/sites use an interactive web-based portal that enables remote review of source documents and CRF data to issue queries and track metrics. Finally, the Submit phase provides sponsors with real-time clinical data formatted according to their existing specifications, including SDTM data formats. Q: Is SureSource accepted by regulators? SureSource is the only platform that meets all FDA guidelines for esource, as outlined in the Agency's September 2013 final guidance on electronic source (esource). In this guidance, FDA clearly states, this guidance promotes capturing source data in electronic form and encourages entering source data during a subject visit for real-time access for data review. Similarly, the EMA has also issued an esource guidance document consistent with the FDA. SureSource has successfully completed a site audit by MHRA and supports the principles outlined in FDA's August 2013 final risk-based monitoring guidance by providing access to source data and documents for remote review and monitoring. Q: How is SureSource accepted by sites? As of Q3 2014, SureSource has been used in more than 50 studies by 3,000+ users, completing 150,000+ visits. According to a recent site feedback survey, 71% of site users agree with the statement, SureSource forms are easy to use; 85% agree with the statement, SureSource saved me time by eliminating CRF data entry. 9

10 Q: Where is the Case Report Form? The purpose of a CRF is to populate the clinical database, however 2013 FDA esource guidance encourages entering clinical data directly into the ecrf with no paper transcription step necessary. In these cases, the SureSource form (esource) is also the CRF there is no separate CRF. The difference is that SureSource forms have additional fields as compared to traditional CRFs. Q: What is the purpose of the additional data fields? The additional data fields in SureSource ensure site adherence to GCP requirements (e.g. verification of informed consent review process; compliance with study-specific data collection requirements [i.e. confirmation that patient was supine for five minutes prior to recording blood pressure]; and other patient safety and medically necessary activities). These fields are always a part of site source documents and are included in SureSource forms (esource) so that sites can use esource during the subject visit instead of creating documentation external to the system. Q: How does SureSource meet privacy standards? SureSource has administrative functions that limit access to patient data by geographic location, user role, and form permissions. These same restrictions can be applied to enforce study blinding rules. Q: What is the typical study build timeline? The SureSource study build is comparable to existing EDC study builds and normally requires 8-10 weeks from final protocol and CRF data specifications. However, SureSource forms incorporate substantially more data points than typical CRFs (on average 35% of the data is CRF data while 65% relates to source fields). Additionally, up to 90% of standard CRF edit checks are built into the esource forms and fire automatically at the time of a subject visit to ensure optimal data and research quality. 10

11 Q: How does SureSource impact Data Managers? SureSource provides significantly more data than traditional EDC systems to provide data managers with a more complete context of clinical data. Data queries are significantly reduced -- as up to 90% of standard CRF edit checks are built into the SureSource forms and fire at the time of the subject visit -- when data can be corrected more easily. SureSource can automate manual data mapping and transposition processes via integrations that connect the SureSource clinical database to various ad-hoc reporting tools (e.g. J-Review, Spotfire, Comprehend). Q: How does SureSource impact Monitors? SureSource eliminates minimally effective and time-intensive monitoring activities -- allowing for more more strategic oversight by providing real-time, remote review of the exact same source documentation and data that would typically require an on-site visit to see. Remote access to source data and documents eliminates the traditional Source Data Verification step. Using the SureSource portal, monitors can access dynamic dashboards and interactive documents that simplify the query management process and guide the review process by identifying key metrics at a study, site, subject and form level. Custom study-specific reports can help further drive a risk-based monitoring process. Q: How does SureSource interact with Electronic Medical Records? Like any EDC system, SureSource does not directly integrate with or replace a site electronic medical record (EMR). However, using SureSource, sites can download source documents as a PDF document for inclusion in a site EMR. Also like EDC, data originally entered into an EMR (e.g. MedHx or ConMeds) must be transcribed into SureSource. Document exports out of an EMR can be uploaded into SureSource for remote review. 11

12 OFFICES 525 Vine Street, Suite 130 Winston-Salem, NC Gibraltar Road, Suite 315 Horsham, PA CentreGreen Way, Suite 200 Cary, NC WORLDWIDE INQUIRIES Phone: Fax: Web: About Clinical Ink Founded in 2007, Clinical Ink is dedicated to transforming clinical development by creating a completely paperless clinical trial platform. Offering the most widely-used esource technology and mobile patient engagement/epro solutions, Clinical Ink streamlines clinical development from Start to Submit. More information about Clinical Ink is available at 12