Monitoring Plan and Standard Operating Procedure
PROTOCOL TITLE: Approved By: Name: Signature: Reviewed By: Name: Signature: Prepared By: Signature: Signature: Role: Date: Role: Date: Role: Date:
Primary o !ective Study design #rial timelines Planned num er of su !ects in the trial Num er of sites Sponsor Data entry and query responsi ilities DSMB$Safety Review Board 5entral la oratory
1. INTRODUCTION Monitoring is necessary to assure adequate protection of the rights of human su !ects and the safety of all su !ects involved in clinical investigations and the quality and integrity of the resulting data su mitted" #he o !ectives the monitoring procedures are: #o ensure that the study is eing carried out in accordance with the approved protocol" #o identify any pro lems and suggest $ see% solutions"
Author: &il ert 'getii( )*MR+,-ellcome #rust Research Programme 0ersion: 12,Nov,3224
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'verall the monitor should e seen 6and ehave7 as a supportive e8tension of the study team" #hey have a professional duty to e impartial and their role is to 9monitor:( and N'# audit" #herefore( the monitor should not e perceived as an outside threat ut part of the team and there to identify any pro lems affecting the conduct and quality of data collected" 2. SCOPE RESPONSI!ILIT":
#his Monitoring Plan also serves as S'P and is applica le to the investigators( study management group( the monitors and study team at each site. #. DE$INITIONS a) MONITORING #he act of overseeing the progress of a clinical study( and of ensuring that it is conducted( recorded( and reported in accordance with the protocol( S'Ps( &ood 5linical Practice 6&5P7( and the applica le regulatory requirement6s7" 7 INVESTIGATOR SITE FILE (ISF) #he repository for the essential documents for the conduct of a clinical trial" #hese documents individually and collectively permit evaluation of the conduct of the study and the quality of the data produced" #hese documents demonstrate the compliance of the sponsor,investigator and of the monitor with standards of &5P and with all applica le regulatory requirements" c7 SOP (Standard Operating Procedure) #his is a document that descri es the agreed procedures of a routine process" '. RESPONSI!ILIT" $OR STUD" MONITORIN( Description of study monitoring arrangement;; e"g" #he 5R' 6company <7 will e responsi le for %!!RE&I%TIONS:
conducting trial monitoring" #he 5R' will appoint an appropriately qualified person6s7 to monitor the trial" #he monitor6s7 will e trained on the study protocol and will e familiar with all study procedures" SITE MONITORIN( SC)EDULE 'rdinarily( a pre study( initiation( routine and close out monitoring are planned and conducted in the life span of a study" #he site initiation visit will e conducted as soon as: All the necessary approvals have een o tained Staff recruited +nvestigational product has een delivered to site 6is a out to e delivered to site7
Author: &il ert 'getii( )*MR+,-ellcome #rust Research Programme 0ersion: 12,Nov,3224
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5R= and source documents are ready >a oratory is ready to start storing study samples
#he first routine monitoring visit will occur as soon as the first participant is recruited or within 3 wee%s of the first participant eing recruited" #he ta le elow provides an estimate of what will e needed in terms of time on site for the monitor" #his needs to e continually assessed y the study management team and the monitors" #he monitoring frequency may need to increase if recruitment is faster than predicted( at times of data entry deadlines 6such as interim analysis or if the DSMB request a safety report7 then two or more people can attend the visit" Site Location Nu*+er Predicted Stud, Start $re-uenc, O. Monitoring
/. MONITORIN( PROCEDURES Monitoring will focus on the following %ey processes of the study so as to ensure protection of rights and well, eing of study participants and integrity of data: ." +nformed consent process" 3" Study eligi ility criteria met for all participants 1" #imely completion of Study 5R=s" /" Accurate a straction of data from clinical and la oratory forms" ?" Sample collection and handling in accordance to Protocol and S'P6s7 @" Review of data management procedure i"e" data entry( handling of data discrepancies and data ac% up" A" Reporting of adverse events and protocols violations according to S'P6s7 B" Drug accounta ility 4" =ollow up assessments and procedures .2" Measures to ensure complete participant follow up" =or each site visit the monitor will wor% according to an agreed schedule of tas%s( including the following that will e given as specifics in the monitoring form and guidelines: Schedule a date with the study investigator$coordinator for the monitoring procedure and provide them with a list or shell of the study sections that will e monitored in this particular visit"
Author: &il ert 'getii( )*MR+,-ellcome #rust Research Programme 0ersion: 12,Nov,3224
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Review last monitoring procedure report" Review the Site study =ile: ensuring that it is updated appropriately" 0erify written informed consents were given for every su !ect entered into the study and o tained according to the consent S'P" Review current status of the study:s participant enrolment vs" anticipated enrolment( losses to follow up( outstanding data issues( reported serious adverse events( outstanding la oratory issues" Review the study forms and data ase ensuring that the participants were eligi le and note any safety issues and protocol violations or deviations" Review la oratory issues: Candling( storage and shipment of samples" Source data verification , a straction of data from clinical and la oratory forms"
During the initial visits the monitors will review .22D of the fields of all the study forms" Su sequently the monitors will review .22D data contri uting to the primary endpoint and .22D of fields for a randomly selected sample of study forms" All forms monitored during a visit will e detailed in the monitoring visit report" A data ase chec% for accuracy of data entry will e performed at regular intervals" #he data points to e chec%ed will e end point data and safety data" After each monitoring visit the monitor will de rief the study team i"e" praise them where they are getting it right and highlight areas which need improvement" #he monitor will then write up a monitoring report citing all findings and status of such findings 6resolved or not7 and forward a signed copy to the sponsor and$or sponsor appointed pro!ect manager" #he monitoring report may e shared with the Principal investigator" At close out visit6s7 the monitor will ensure all queries are resolvedE the study product is accounted for and returned or destroyed according to sponsor S'PE and study documents are properly archived" #he comprehensive list of activities during this visit6s7 will e detailed in a study close out S'P" 0. %PPENDICES A" Site initiation visit chec%list B" Routine Monitoring S'P 5" Routine Monitoring Report template D" Study =ile 5hec%list *" 5lose out visit S'P
Author: &il ert 'getii( )*MR+,-ellcome #rust Research Programme 0ersion: 12,Nov,3224
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