Research Coordinator Resources

 

New Training Courses

Two new courses are being offered for your training needs, which are:

1) EeMR Documentation Training for Research Nurses
Research nurses can document subject’s research visit, consent process, and other relative research information in EeMR.  The next training course is Tuesday, June 13 from 1:00 – 2:00 pm at 1599 Clifton Road, 1st Floor, Room 1.380.  Registration information can be found at http://ocr.emory.edu/training/courses.html. Research nurses must have “Document Viewing” on the EeMR Navigational Menu before coming to training. Contact your department’s Access Coordinator for EeMR access and navigational settings.  

2) Phlebotomy 101 Training: Introduction to Venipuncture

Emory University and Emory Healthcare employees can learn the essentials to phlebotomy through ACTSI and Emory Medical Laboratory.  Registration is open for the months of August, October, and December. View the attached documents for more course details or at http://ocr.emory.edu/training/courses.html.

Course Introductory Letter

 

Epic Upgrade

Children's Healthcare of Atlanta will be updating Epic on June 21st. Please click here for more information and training opportunities.

For any questions regarding the Epic upgrade, ploease contact:

Andrea Morgan, CHOA Technical Trainer: andrea.morgan@choa.org; 404-785-5923

ERMS update Beginning March 1, 2017, clinical research nurses and coordinators who are enrolling patients in ERMS must track patient study visits on the same day of the research visit. Doing so will ensure that grant accounts are reconciled promptly
DOP CRC Certification Guidelines

The Department of Pediatrics has budgeted funds to reimburse clinical research staff for their initial certification through ACRP or SoCRA

DOP Guidelines for CRC Certifications

Please contact Amanda Cook for more information.

SoCRA Exam-Atlanta, Ga

Date: September 13, 2017

Location: TBD

Time: 8:00-12:00

  1. Determine if you are eligible for the exam. Eligibility Criteria
  2. Apply for the exam. Application
  3. SoCRA Certification Quick Facts
  4. Please review the local Atlanta chapter website for upcoming training sessions. www.atlsocra.org

 


 

Title Meeting Date Meeting Location Description
Ongoing Continuing Medical Education (CME) Opportunities Varies Varies Emory Office of Continuing Medical Education

The Pediatric EducAtion Research Lunch Series (P.E.A.R.L.S.) was created specifically for coordinators and research nurses working in Pediatrics. Topics were identified from the March 2016 CRC/CRN survey responses that were collected from Department of Pediatrics and CHOA research coordinators and nurses. Each session will have a panel of "experts" available to discuss topics and answer questions.

All programs are from 12:00pm-1:00pm

Date Topic Slides
04/08/2016 Research Resources 

  

Research Resources

ACTSI

 

6/10/2016 IRB Submissions-What are your questions IRB Submissions-Q & A
10/14/2016    Billing Compliance Research Billing Compliance
12/09/2016 Study Start-up and Implementation Study Start-up

CHOA Mentors for Clinical Research Support Services

Resources

The Research Coordinator/Nurse oversees and coordinates the daily activities of clinical research studies. They work closely with the clinical teams and investigators to ensure that all protocol required procedures and visits occur according to protocol specified guidelines. Research Coordinators/ Research Nurses generally manage subject enrollment and ensure compliance with the protocol and other applicable regulations. This includes but is not limited to

  • Subject recruitment
  • Obtaining informed consent
  • Educating subjects on the details of the research study
  • Assessing subject eligibility
  • Facilitating subject care and follow-up per protocol
  • Creating source documentation
  • Assisting in the assessment of toxicities/adverse events
  • Reporting serious adverse events per IRB and sponsor requirements

Please see your immediate supervisor if you would like a detailed job description

Clinic Visits

For research appointments that need to be scheduled in the outpatient/inpatient clinics at CHOA, independent of the patient’s medical appointments, most of the scheduling is done by the hospital schedulers utilizing EPIC. However, it is still the responsibility of the research staff to communicate the specifics of the protocol visit, including timing of the visits scheduled, how long visits are expected to take, complete any paperwork necessary, obtain physician order for lab or special testing that needs to be performed at a given visit.

 

Pediatric Research Center (PRC)

  • Location: Tower 2 Butterfly elevators 2nd FL, inside the TDICU
  • Hours of Operation: Monday-Friay; 8:00am-5:00pm
  • Scheduling: Visits must be scheduled in CR Assist by at least 48 hours in advance  of the visit.
  • Phone: 404-785-0400
  • Email: PRC@choa.org
  • Website: https://www.choa.org/research/research-center

 

Emory Children's Center Research Unit (ECC-RU)

  • Location: 2015 Uppergate Drive Atlanta, GA 30322:1st Floor, Rooms: 148D, 150A, 150B, and 150C
  • Hours of Operation: Monday-Friday; 8:00am-5:00pm
  • Scheduling: Click here to access the online scheduling system.
  • Phone: 404-727-4888
  • Email: ECC-RU@emory.edu

 

Investigational Drug Service Pharmacy (IDS)

  • Location: 1405 Clifton Rd, 1st FL
  • Hours of Operation: Monday-Friday; 8:00am-4:30pm
  • Scheduling: Advanced notification for scheduled patient visits will be provided to the pharmacy as soon as the patient visit has been scheduled.  Contact IDS in advance to schedule pharmacy monitoring visits.
  • Phone: 404-785-1281
  • Email: idsrx@choa.org

 

Clinical Research Laboratory

  • Location: 1405 Clifton Rd, 1st FL
  • Hours of Operation: Monday-Friday, 8:00am-4:30pm
  • Scheduling: All time sensitive lab sample processing must be approved at least 48 hours in advance. Unscheduled patients with same day, time sensitive lab processing require a minimum of 2-hour notice directly to lab personnel.
  • Phone: 404-785-1281 (Egleston); 404-785-0342 (Scottish Rite)
  • Email: heather.macdonald@choa.org

 

Additional Links:

PRC Submission Guidelines

ECC-RU FAQs

 

Before hours, after hours or weekend and holiday services may be considered upon request based on staff availability and will require prior notification. For laboratory, additional fees may be imposed on those studies requiring after hours/weekend processing.

Please ensure the following has been completed upon approval of your study

  • Enter study into the CHOA Project Enrollment Tracker: Once a notice of award (NOA) is issued for a clinical trial ,a project enrollment tracker must be created and updated after each patient visit. Project Enrollment Tracker Procedures
  • Email the CHOA IRB Authorization Agreement (IAA) Reliance Acknowledgement Form to irb@choa.org. This form is used for new studies that have an IRB Authorization Agreement (IAA) with another institution, or when your research falls under the umbrella agreement with Emory, Georgia Tech, or Morehouse.  Please contact the CHOA IRB if you need assistance determining whether or not you should complete this form.
  • Enter your study into the Enrollment and Visit Tracking Database
  • Complete the ERMS Activation Form. ERMS is a web-based clinical research financial management tool used to assist Emory Healthcare and Emory University with their joint research billing compliance program. It facilitates communication of subject enrollment and study visit activity by the research team with the billing departments. If you have an Emory PI and they will conduct a pediatric clinical trial, the form must be completed. Please visit the ERMS webiste for more information and to access the form.

 

You will need to update the following for each enrollment or visit

  • Complete the patient pre-registration form for visits that will generate a CHOA billable. The form must be completed at least a day prior to the research visit or on the same day as consenting.
  • Complete the patient tracker after each visit
  • Enter newly consented subjects into ERMS

 

You will need to update the following monthly

  • Update the Enrollment and Visit Tracking Database (All study data is to be entered by the 10th of the following month (example: August data is due by September 10th). After the 10th, the data will be locked and you cannot make edits. Please also remember to save your data as “complete” at the bottom of the page). Database manager: Mary Smith, mary.smith4@choa.org, 404-785-6234
  • Update the Project Enrollment Tracker

 

You will need to update the following upon study closure

Source Documents

A source document is where data is first recorded. Examples of source documents include: medical records, phone encounters or notes, lab and diagnostic test results, subject diaries, and research worksheets used to document key research data elements. Utilization of the source document helps ensure protocol and regulatory compliance and can be subject to review when validating the integrity of data collection and analysis. The research team should thoroughly document the details of the tasks or procedures completed and any other pertinent research information conducted during each subject visit in a source document.

 

Case Report/Record Forms (CRFs)

Most industry sponsored trials will provide either paper Case Report Forms (CRFs) or access to Electronic Case Report Forms (eCRFs).   The CRFs identify all of the data elements required by the sponsor and should correlate with the required data elements outlined in the protocol.  Study site staff transcribes information from relevant source documents to the CRFs or eCRFs. 

  • All paper entries should be completed legibly in black ink
  • The Principal Investigator (PI) or their designee(s) may enter data on the CRFs and make corrections to the original CRFs as long as they are listed on the Delegation of Authority Log (DOA).
  • Only acceptable medical terminology and approved institution abbreviations should be used.
  • Avoid leaving blank data fields, using question marks, and using zeros as a response on CRFs.  Determine the acceptable abbreviations to be used for the following scenarios:  data not available, data not applicable and not done.
  • When making corrections on paper documents, either the source document or CRF, draw a line through the previously written mistake, initial and date next to it. You should then write the correction next to this. The correction should not obscure the original entry. This is important because an audit trail must be maintained.

The study monitor (CRA) or central data coordinator will often review the CRFs for legibility, completeness and consistency.  Any data that is missing or errors identified by the study coordinator or monitor will need to be resolved.  For some studies this will be completed before the data can be sent to the Contract Research Organization (CRO) or Sponsor.  Other studies may use data verifiers that screen all data fields and generate queries that are sent to the study center requesting corrections to the primary study document and electronic correction in the data base.  The explanation of missing data or data irregularities, including deviations from study protocol may require an explanation in the form of a memo/note to file.

 

Data Collection Tools  

For investigator initiated research studies, the research team is responsible for identifying the tools and mechanism for data collection and analysis.  It is helpful to always have a biostatistician involved in the development of the tools and determination of data points that must be analyzed to support the research study objectives.  Data can be collected and analyzed in simple programs like Excel or more complex research data management systems. If a simple program like Excel will be used, it must be password protected, have limited access to key personnel involved in the research study and be stored as stated in the IRB approved protocol, explaining how confidentiality of patient records and research data is protected. It is recommended that secure data management systems are utilized for human subjects data collection.

REDCap is an open source tool that provides study staff with tools to manage projects, participants and research data. 

Emory REDCap

CHOA REDCap Request Form

 

Maintenance and Storage of Research Records

Research records should be stored according to IRB requirements for at least three years after the completion of the research study or longer if required by the sponsor or your institution.  FDA regulations state that study records must be stored for at least two years past the date of approval of a New Drug Application (NDA) or discontinuation of the research study if a NDA will not be submitted by the sponsor.

 

Long Term Storage

Some clinical trials may require records to be stored for an extended period time. Please refer to your sponsor for specifics and/or you may visit the Emory Records Management site for more guidance.

The Department of Pediatrics has an off site records storage account with Access. Please contact Amanda Cook for more information.

 

Additional Resources:

Research Study Templates-Clinical Trials Tools

Research teams should have regular review of their research records to ensure compliance with the IRB approved protocol and adherence to institutional, state, and federal guidance and regulations. This can be achieved by a designated internal clinical research compliance auditor or by developing internal checks and balances.

 

Key elements to review through a peer reviewed compliance review

Consent: Ensure completed correctly, that they were signed prior to any research related activity was conducted, and that a written consent note detailing the consent process was completed and filed appropriately.

Eligibility: Ensure that source documentation exists to support that all inclusion and exclusion criteria were met prior to enrollment. Provide information that all procedures/tests were completed within the required timeline.

Study Intervention: Verify study specific tests, interventions, and visits are completed per protocol guidelines. Confirm that note to files are available to explain any deviations from the protocol guidelines and that source documentation exists for every study visit.

Adverse Events: All adverse events (AE) and severe adverse events (SAE) should be documented, categorized, and reported correctly and within the specified reporting timelines.

Data Completion: Verify all CRFs/eCRFs are completed within the required timeline specified by the protocol and corrections are documented correctly

Drug Accountability: Ensure drug accountability logs are completed correctly. Tracking should be provided for drug received, delivered, dispensed, and returned.

Regulatory Files: Review consent elements, ensure compliance to most updated protocol, review amendments, continuing reviews, etc. 

 

Additional Resources

FDA monitoring information

Emory Clinical Trials Audit and Compliance

CHOA Research Administration

An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is death, life-threatening, hospitalization (initial or prolonged), disability/permanent damage, congenital anomaly/birth defect, requires intervention to prevent permanent impairment or damage (Devices), or other serious important medical events. Please visit FDA website for more detailed description on each event.

CHOA IRB Reporting Guidance

CHOA IRB Forms

Emory IRB Reporting Guidance and Forms (includes Veterans Affairs)

Study sites are monitored to ensure oversight of the clinical research study by the sponsor. Types of monitor visits include, pre-study visits, initiation visits, periodic monitoring visits, and close-out visits.  Study sites may also be monitored or audited by the FDA, Clinical Research Organizations (CROs), IRBs and sponsors. 

Pre-Study Visit: Pre-study visits include site selection visits (SSV) or site qualification visits (SQV). They are conducted to determine if the investigator and clinical site have the capability to conduct the study. During the visit, the coordinator and the investigator must be available. When applicable, pharmacy staff and other ancillary services staff may need to be available as well.

Initiation Visits: A site initiation visit (SIV) is conducted when a research site is ready to be activated for recruitment. These usually occur after the site has completed all regulatory requirements, has IRB approval, and an executed contract. This is the last step before the study site is activated for enrollment by the sponsor.

Interim/Periodic Monitoring Visits (IMV): The sponsor/CRO will develop a monitoring plan that includes the frequency and duration of periodic monitor visits. The focus of these visits is to evaluate the way the study is being conducted and to perform source document verification.

Close-Out Visits: When the research study has been completed at a site, a close-out visit occurs. The visit can be conducted via telephone or on-site. Close out visits may be scheduled in conjunction with the final periodic monitoring visit.

 

How to prepare for your IMV

  • Identify a quiet place for your monitor to work
  • Schedule time with investigational drug services and other ancillary services as applicable
  • Complete all necessary CRFs
  • Confirm all SAE forms have been submitted and are available for review
  • Obtain source documents for the CRFs to be reviewed
  •  Request Epic or powerchart monitoring access
  • Confirm that signed consent forms for all enrolled participants are available
  • Schedule time for the coordinator to meet with the monitor towards the end of the visit to review findings
  • Schedule time for the investigator to meet with the monitor towards the end of the visit to review findings

 

Requesting data/safety monitor for Emory investigator initiated drug studies: Site Monitor Request 

 

How to request monitoring chart access:

CHOA (EPIC): Please review the CHOA research monitoring access guidelines

 

Emory (Powerchart):

If you have study monitors that will need to review subjects charts in EeMR, please contact the following people for the appropriate forms for the locations indicated:

 

Reminders:

Email Clinical Trials Auditing and Compliance the monitoring report after each visit for studies using Emory IRB and email CHOA Compliance for CHOA IRB studies