To request participation in a SoCRA exam study group, contact Mary Mungai

CCTR Monitoring Program Guidelines

Clinical research monitoring is a key part of the clinical research process, ensuring the safety and accuracy of results. The Center for Clinical and Translation Research (CCTR) is offering monitoring services in the following situations:

• The study is conducted by a Principal Investigator that is in the Department of Pediatrics; AND
• The study is investigator-initiated; AND
• The study is limited to a single-site; AND
• Monitoring is required, but not offered by the sponsor/institution.

Requests for monitoring must be submitted in advance of IRB approval of a monitoring plan to Mary Mungai (mary.mungai@emory.edu).  CCTR must approve language to be included in submission and study documents. 

Requests will be considered on a first come first served basis.  If the CCTR is capacity for monitoring services or is otherwise unable to monitor the study , the study team will be responsible for securing monitoring elsewhere.

The Department of Pediatrics provides a courier for non-urgent research samples from the Center for Advanced Pediatrics (CAP) to the Health Sciences Research Building (HSRB), specifically to the Emory University Children’s Clinical and Translational Discovery Core (CTDC).  Samples are picked up around 3:00 pm Monday - Friday

Addresses:

Children’s Healthcare of Atlanta

Center for Advanced Pediatrics (CAP)

1400 Tullie Rd. NE, Room 5216

Atlanta, GA 30329

Emory University Children’s Clilnical and Translational Discovery Core (CTDC)

1760 Haygood Dr., E-264

Atlanta, GA 30322

Teams that need to have their research samples brought over to HSRB from CAP will need to fill out the Sample Transport Log. 

The Sample Transport Log can be found in Appendix V of the SOPs. 

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 Unit (PRU)

• Location: CAP
• 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: 164, 170, 172, and 173
• Hours of Operation: Monday-Friday; 8:00am-5:00pm (after hours visits available upon request)
• 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

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

• 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.
• If you have a study with Emory billables, you will need to complete the OCR Submission Form - must be on the Emory network or signed in to Emory VPN to access form. OnCore is a web-based enterprise-wide clinical trials management system (CTMS) that will simplify the management of clinical research and integrate multiple functions including protocol administration, participant tracking, and sponsor invoicing. OnCore CTMS will align with the Emory Healthcare Epic electronic medical record system to reduce redundancy across the enterprise and to enhance patient safety and research billing compliance. Please click here for more information.

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 Sarah Marie Huban for more information.

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

Emory Clinical Trials Audit and Compliance

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: contact Sarah Marie Huban.

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:

• EUH, EUMH, WW, and EUOSH  - Audrey Faison, HIM Operations Manager, 404-712-1690, audrey.faison@emoryhealthcare.org
• Emory Johns Creek - Sandra Larry, Director, HIM, EJC & ESJH, sandra.larry@emoryhealthcare.org
• Emory St. Joseph - Patricia Wilson, Secretary, 678-843-7306, patricia.wilson@emoryhealthcare.org
• The Emory Clinic - Brittany Tharp, Supervisor, 404-778-3808,  brittany.tharp@emoryhealthcare.org

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