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:
- Demographic Information
- Trial screening form
- Pretreatment assessment
- Radiotherapy plan details
- Radiotherapy plan QA details
- Radiotherapy treatment setup inaccuracy data
- Radiotherapy treatment review form
- Follow up review form
- Outcome form.
- QoL capture form
- 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:
- Subject’s name, contact information and protocol identification.
- The date that the subject entered the study, and the subject number.
- A statement that informed consent was obtained (including the date).
- Relevant medical history
- Dates of all subject visits and results of key trial parameters.
- Occurrence and status of any adverse events.
- 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.