A Real-World Evidence Study Evaluating Quality of Life Parameters Following Treatment With Otrivine (Xylometazoline Hydrochloride)
Phase: PHASE4
Conditions: Common Cold
Sponsor: HALEON

This document contains confidentiality statements that are not relevant for
this publicly available version
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218317 Protocol Amendment 07 Dec 20221TMF-24180711.0 
GSK Consumer Healthcare 
Clinical Protocol 
Protocol Number: 218317 
All eCRF pages should be completed during a subject assessment when the eCRF has been 
designated as the source. 
GSK CH will obtain and retain all eCRFs and associated study data as applicable at the 
completion of the study. 
Identifiable data are isolated to a special team at 
and these data will not be 
transferred/available to GSK CH. 
11.2 
Data Handling 
Documentation of all data management activities should allow step-by-step retrospective 
assessment of data quality and study performance. 
Any changes or corrections to data will be performed in the
Electronic Data 
Capture (EDC) Platform, and it will include rationale for changes. The EDC system has 
an audit trail, which will provide a complete record of the changes and corrections 
endorsed by the investigator/designee. 
Adverse events will be coded using Medical Dictionary for Regulatory Activities 
(MedDRA) and any concomitant medications terms (if applicable) using a validated 
medication dictionary, WHODrug. 
11.2.1 
Data Queries 
The
data management team will perform edit checks as the data are being 
entered into the system, and queries will be entered on a Data Issues Log for the 
decentralized site staff to address.
will raise queries as needed on safety data 
to code the terms (AEs and Drugs or concomitant medication) appropriately. 
The study monitor will perform ongoing review the of the eCRFs in accordance with the 
monitoring plan, to confirm that data entered into the eCRF by authorized site personnel 
are accurate, complete, and verifiable from source documents; that the safety and rights of 
subjects are being protected; and that the study is being conducted in accordance with the 
currently approved protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
11.3 
Processing Patient Reported Outcomes 
Electronic Patient reported outcome ( ePRO) data will be collected using electronic devices 
and transferred electronically to GSK CH or
All ePRO source data should be reviewed by the study staff and the study monitor to ensure 
accurate transcription of data and that any potential AEs or concomitant medications 
reported on these documents are discussed with the subject and transcribed accurately to 
the eCRF and/or OMS. ePROs that are classed as source data will be retained by the 
investigator and true/certified copies may be sent to a designated vendor or GSK CH as 
Property of GSK Consumer Healthcare - Confidential 
May not be used, divulged, published or otherwise disclosed without the consent of GSKCH 
 Clinical Protocol Template v9.0 
Page 42 of 62
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