Data collection and Management

Plans for assessment and collection of outcomes {18a}

Data related to the trial will be collected and maintained on a RedCap database maintained in Tata Medical Center. The randomization module of RedCap will be used for random allocation into the two arms. Participating institutes will have access to the RedCap data entry system. The RedCap data forms can be printed out and used as such for clinical data entry in the trial if paper form entry is needed. The following forms will be created in Redcap for the data collection purpose:
  1. Demographic Information
  2. Trial screening form
  3. Pretreatment assessment
  4. Radiotherapy plan details
  5. Radiotherapy plan QA details
  6. Radiotherapy treatment setup inaccuracy data
  7. Radiotherapy treatment review form
  8. Follow up review form
  9. Outcome form.
  10. QoL capture form
  11. SAE reporting form
The RedCap features for longitudinal data collection as well as repeating forms will be utilized for data collection. RedCap also has the facility to set up rules for data quality assurance which will be used to ensure that entered data is of high quality. Planning CT and treatment plan data will be archived in an image bank which is concurrently undergoing development in our institute (34).

Plans to promote participant retention and complete follow-up {18b}

If a patient or investigator decides to stop the study treatment then the patient’s health status will be periodically reviewed via continued study visits or phone contact, or from their general practitioner or medical records to allow collection of outcomes data. Follow-up assessments including completion of the quality of life questionnaires should still be completed if the patient is willing.
In the event that a patient withdraws from the study entirely, the effective date of the notification will be the date on which their withdrawal is received by the study team. No information about the patient will be collected from that point in time onwards but any information collected prior to that date can be used and forms part of this study.
For patients moving from the area during follow up, every effort should be made for the patient to be followed up at another participating trial centre and for that trial centre to take over responsibility for the patient. A copy of the patient Case Record Forms (CRF) will need to be provided to the new site after appropriate patient consent. Until the new centre agrees (in writing) to take over responsibility, the patient remains the responsibility of the original centre.

Data management {19}

Access to the data will be available to the principal investigator of the study as well as to the co-investigators. The data quality and integrity will be checked at quarterly intervals using the data quality checking system available in Redcap. Patient identifiers will be noted as such in the Redcap database and the same will be used for ensuring that any data exports contain de-identified data only. Institutes will have access to the data of their own institute during the trial phase. Once the trial is completed the main database will be checked for data consistency and quality and then closed for analysis. Additionally, the PI will be asked to sign off key CRFs electronically to ensure completeness and accuracy of the data.
Source documents pertaining to the trial must be maintained by investigational sites. Source documents may include a subject’s medical records, hospital charts, clinic charts, the investigator’s subject study files, as well as the results of diagnostic tests such as X-rays, laboratory tests, and electrocardiograms. The investigator’s copy of the case report forms serves as part of the investigator’s record of a subject’s study-related data. All study-related documentation will be maintained for 10 years following completion of the study or according to existing regulatory requirements.
The following information should be entered into the subject’s medical record:
  1. Subject’s name, contact information and protocol identification.
  2. The date that the subject entered the study, and the subject number.
  3. A statement that informed consent was obtained (including the date).
  4. Relevant medical history
  5. Dates of all subject visits and results of key trial parameters.
  6. Occurrence and status of any adverse events.
  7. The date the subject exited the study, and a notation as to whether the subject completed the study or reason for discontinuation

Confidentiality {27}

The study will be conducted in accordance with applicable rules and regulations. All data generated in this study will remain confidential. All information will be stored securely at the sponsoring institute and will only be available to staff directly involved with the study. For documents transferred between institutions the data will be securely stored in the RedCap database and access restricted to the trial institute and the CTU through the use of the data access groups features in RedCap.

Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}

Blood will be collected at the beginning and end of radiotherapy for consenting patients. 10 mL of venous blood will be collected and stored in a Ethylene Diamine Tetraacetate (EDTA) blood tube. The sample will be processed for storing the plasma and buffy coat separately in the biobank. Future studies will be designed to utilize these biospecimens for correlative translational studies investigating fraction sensitivity.