IROC REPORT Ying Xiao, PhD, Philadelphia, PA, Huaizhi Geng, PhD, Bryn Mawr, PA, Denise Manfredi, BS

What is TRIAD and how to use TRIAD for NCTN Clinical Trial Digital Data Submission

As a clinical physicist, you come to work one day and receive an urgent message from one of the research associates (RA) from your clinical trial group: your institution is participating in a new multicenter clinical trial from NCTN and there is a requirement to submit DICOM digital data through TRIAD.

What do you do?

Here is some background information and guidelines to walk you and your RA through the process.

TRIAD is a web-based application that securely moves medical images and related data across the Internet. The data transmitted can include DICOM images, both structured and unstructured radiology reports, and radiotherapy treatment planning data. It meets FDA regulatory requirements under Title 21 CFR Part 11 that governs using electronic records in clinical trials. It was developed and is maintained by the American College of Radiology (ACR) with a focus on userfriendliness. TRIAD's application programming interface enables integration with Rave NCI's clinical trial database) and electronic data capture systems (EDC).

TRIAD is tightly integrated with the NCI's National Clinical Trial Network (NCTN) core systems, allowing research personnel at NCTN participating sites to submit data and images for the trials that are a part of NCTN. NCTN TRIAD users must utilize a CTEP-IAM user name and password to log in.

1. Obtain CTEP IAM account
   If you do not already have a CTEP IAM account, please use this link and follow the steps to apply for one.
2. Have your Lead RA add you to the enrolling site Roster as a TRIAD SITE USER, If you cover multiple sites that enroll patients, you must be added to all of the site rosters.
3. Install TRIAD Client and establish data transmission pathway
   Work with your Department IT specialist to install TRIAD. For more information on how to install and use TRIAD, please refer to this link.
4. TRIAD digital data submission
   
   1. Login with CTEP IAM account, select Clinical Trials (NCI Oncology) from drop down
      
      
   2. After login: Go to the submission tab, select the trial & site, choose the digital file(s) for submission.
      
      
   3. Items to be noted for submission:
      
      1. TRIAD provides features for submitting files from multiple sources:
         1. Local computer / network drive: Files can be located in local computer folders, local CD/DVD drives or network drives. There are two ways to get upload data: Files: User can select single or multiple files. Folders: User can select a folder and by selecting folder, all files in the folder will also be selected automatically
         2. PACS: TRIAD has the ability to query PACS for the study to submit. Either establish a DICOM query/retrieve through DICOM servers or DICOM data export for submission selection.
      2. Entire data sets must be submitted (CT, RT Dose, RT Structure, RT Plan). If resubmission is required the entire data set must be submitted again.
      3. Never submit zipped files, they do not go through the anonymization process zipped.
      4. A DDSI form must be completed after each submission. Your CTEP IAM login is also used for this.
   4. TRIAD validation profile:
      A uniform radiation therapy structure name library was developed to use a single set of consistent structure names (Yu et al. 2014). The standard structure names for required structures by the trial protocol is listed in TRIAD validation profiles developed by IROC in collaboration with NRG Oncology and AAPM (refer to this site for NRG structure name library). In the following screen shot, when a submission passes the validation a check mark is shown and a cross is shown otherwise.