Protocol Title : A Randomised, open labelled study in anti ... - EME
Protocol Title : A Randomised, open labelled study in anti ... - EME
Protocol Title : A Randomised, open labelled study in anti ... - EME
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
<strong>Protocol</strong> Version 3 14/01/2013<br />
The <strong>study</strong> will be submitted to and approved by a ma<strong>in</strong> Research Ethics Committee (REC) .<br />
Changes <strong>in</strong> protocol that may <strong>in</strong>crease the exposure to risk or present new risks to the patient, or<br />
may adversely affect the validity of the <strong>study</strong>, must be approved <strong>in</strong> writ<strong>in</strong>g by the sponsor and then<br />
the IRB/EC before the change is implemented. These changes are usually presented <strong>in</strong> the form<br />
of an amendment.<br />
The <strong>study</strong> will be regularly reviewed the <strong>in</strong>-house monitor<strong>in</strong>g and ethics committee. This will be<br />
done to verify that data is be<strong>in</strong>g accurately recorded and documented. Further, the committee will<br />
rout<strong>in</strong>ely review <strong>study</strong> documents with an eye towards ensur<strong>in</strong>g that the <strong>study</strong> protocol is<br />
accurately followed and GCP compliant.<br />
8.5 Quality Control and Quality Assurance<br />
8.5.1 Summary Monitor<strong>in</strong>g Plan<br />
Please See Monitor<strong>in</strong>g Plan for full details<br />
On-Site Monitor<strong>in</strong>g will be carried out on this trial. The trial monitor will perform the first monitor<strong>in</strong>g<br />
visit with<strong>in</strong> 1 month of the first patient be<strong>in</strong>g enrolled at a site.<br />
Monitor<strong>in</strong>g visits will be performed a m<strong>in</strong>imum of twice a year dur<strong>in</strong>g recruitment and treatment<br />
period.<br />
The frequency visits may change (<strong>in</strong>crease or decrease) depend<strong>in</strong>g on the issues raised dur<strong>in</strong>g the<br />
trial (death, SAE, audit or <strong>in</strong>spections, site not recruit<strong>in</strong>g). Any decrease <strong>in</strong> monitor<strong>in</strong>g at a site will<br />
be approved by a member of the CECM Management Team and the Sponsor.<br />
Source Data Verification<br />
100 % SDV will be performed on <strong>in</strong>formed consent<br />
100 % SDV will be performed on <strong>in</strong>clusion / exclusion criteria<br />
100% SDV on all data po<strong>in</strong>ts will be performed for a m<strong>in</strong>imum of one patient per site or<br />
approximately 5% of all patients, whichever is greater.<br />
If for some reason on-site monitor<strong>in</strong>g cannot be completed as per the above schedule the<br />
Sponsors Self Monitor<strong>in</strong>g Form will be sent out to sites for completion at these timel<strong>in</strong>es. Reasons<br />
for not perform<strong>in</strong>g on-site monitor<strong>in</strong>g must be agreed with the Sponsor and fully documented <strong>in</strong> the<br />
TMF.<br />
The follow<strong>in</strong>g central facilities are utilised <strong>in</strong> this trial and will undergo yearly monitor<strong>in</strong>g visits for<br />
the duration of their participation <strong>in</strong> the trial:<br />
* EMR Laboratory (<strong>in</strong>sert right name)<br />
* Barts Health NHS pathology lab<br />
A summary of all monitor<strong>in</strong>g activity for this <strong>study</strong> will be provided to the Sponsor every 6 months.<br />
8.5.2 Audit and Inspection<br />
Audit<strong>in</strong>g: Def<strong>in</strong>ition “A systematic and <strong>in</strong>dependent exam<strong>in</strong>ation of trial related activities and<br />
documents to determ<strong>in</strong>e whether the evaluated trial related activities were conducted, and the data<br />
were recorded, analysed and accurately reported accord<strong>in</strong>g to the protocol, sponsor's standard<br />
operat<strong>in</strong>g procedures (SOPs), Good Cl<strong>in</strong>ical Practice (GCP), and the applicable regulatory<br />
requirement(s).”<br />
Study: R4RA EudraCT: 2012-002535-28 35 / 34