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A Day in the Life of a Clinical Research Associate

According to ICH GCP (5.18.1) the purpose of trial monitoring is to verify that:

a) The rights and well-being of human subjects are protected.

b) The reported trial data are accurate, complete and verifiable from source documents.

c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirements.

The responsibilities of the monitor are outlined in section 5.18.4 of the ICH GCP Guidelines (a copy can be downloaded from www.ifpma.org/ich5e, click on E6:GCP). The monitor is required to follow the Sponsor's established Standard Operating Procedures (SOPs) and any study-specific procedures.

Most CRAs are required to travel at least 50-60% of the time (3 days a week) - interstate and sometimes to New Zealand. At times they may be out of the office for a week at a time, depending on the site/monitoring workload. This often means an early start and/or a late finish as Company's expect CRAs to put in a full days work on-site (arrive by 8:30am and leave at 5:00pm). Obviously there is some flexibility but it is not unusual for CRAs to get on a 6:30am flight and not get home until 8:00pm or later.

CRAs with 0-2 yrs experience tend to be given the site management and monitoring activities for a specific number of sites (10 on average). All aspects of managing these sites and their activities are the responsibility of the CRA. Any issues can be discussed with the Senior CRA and/or Project Manager.

As CRAs gain more experience they take on more responsibilities ie. project management tasks. They may not take on a whole trial initially but aspects of the trial (specific tasks) may be delegated. For example, they may be given responsibility for writing study-specific procedures; managing the Central Laboratory; co-ordinating drug supplies.

With several years experience under their belt a CRA should be able to manage a trial from start to finish, co-ordinating all activities and delegating to project team members, as appropriate, to ensure that the trial is conducted on schedule, within budget and to the required standards.

Activities in the Office:

Pre-Study:

• Site selection activities - contact potential investigators to discuss the proposed study and arrange Pre-Study visits as appropriate; following the visits, document activities and recommendations in a Pre-Study Visit Report;
• For sites selected for study participation, assist site staff with IEC submission activities - help with completion of IEC application forms and provide any necessary information or documentation (protocol; Investigator Brochure; Patient Information Sheet and Informed Consent forms; indemnity; advertisements); assist investigator in answering IEC queries to ensure IEC approval.
• Negotiate financial agreements with investigators.
• Answer any study-specific queries raised by site staff.
• Liaise with Regulatory affairs/obtain regulatory approval for study/sites;
• Prepare/write study-specific documentation - forms and procedures, including tracking spreadsheets for documents, patient recruitment, CRFs, data queries.
• Liaise with Head Office/Data Management with regards to design, review, (translation if necessary), production and delivery of CRFs/Patient Diary Cards/Questionnaires.
• Liaise with the Central (or Local) Laboratory to organize production of lab kits, lab manual, shipping/handling of samples and reporting of results;
• Liaise with Head Office/local Drug Depot to order clinical supplies, arrange labelling, shipping, tracking and accountability; ensure randomization procedures are in place.

Initiation:

• Compile Investigator Files with all appropriate GCP/regulatory documentation and trial procedures (ie. IEC correspondence and approval; CVs; signed protocol; Investigator Brochure; regulatory approval; indemnity; signed financial agreement; drug shipping records; drug storage and dispensing procedures; lab manual, reference ranges etc.),
• Ensure all required documentation is complete prior to site initiation and dispatch of drug to site.
• Participate in preparation and presentation of Investigator Meeting.
• Arrange shipment of all study and drug supplies to the site.
• Arrange Initiation visits and following the visits, document activities in an Initiation Visit Report.

Monitoring:

• Answer study specific queries from site staff ie. study-coordinators, investigators, pharmacists;
• Manage patient recruitment strategies to ensure target patient numbers are met ie. prepare study Newsletters, advertising campaigns, investigator meetings etc.
• Ensure that Serious Adverse Events are reported according to SOPs;
• For any protocol amendments, ensure that IEC approval is obtained and all necessary documentation is filed.
• Arrange Monitoring visits at appropriate time intervals (depending on rate of recruitment, number of patients enrolled and complexity of the study);
• Write up Monitoring Reports to summarise the monitoring activities including significant findings, deviations, deficiencies and any recommended actions to be taken. Based on the findings, prepare follow-up letters to Investigators;
• Follow-up and resolve any issues arising from Monitoring visits;
• Participate in global/local conference calls and meetings to review progress of ongoing trials;
• Track completed CRFs sent to Data Management; track issued and resolved data queries;
• Maintain in-house project files to ensure complete documentation, including all correspondence.

Close-Out:

• Ensure any outstanding documentation is filed (including drug accountability and destruction records) and archive project files according to company SOPs, ensuring retention for the required time (at least 15 years).
• Arrange Close-Out visits with sites and organize on-site or off-site archiving; document activities in a Close-Out (Final) Monitoring Report.

Activities at Investigator Sites:

Pre-Study Visits:

• Visit potential investigational sites to determine their suitability to conduct a trial. Meet with the invesitagator/site staff to ensure they are suitably qualified and the investigator has adequate resources and facilities to conduct the trial.

Initiation Visits:

• Visit sites selected for trial participation and ensure they are set-up and trained prior to recruitment of the first patient.
• Ensure all GCP/regulatory documentation is complete (filed in the Investigator File) and the protocol, Case Report Form (CRF) and all trial procedures have been reviewed and the staff fully trained.
• Ensure all study and drug supplies have been delivered to the site (if appropriate) and conduct an inventory.

Monitoring Visits:

Visit sites every 4-6 weeks to ensure the trial is being conducted according to the protocol, ICH GCP and company SOPs. Perform the following tasks:

• Review Investigator File to ensure all regulatory and GCP documentation is complete ie. Subject Screening and Enrolment Logs; Drug Shipment, Dispensing and Accountability Logs; Serious Adverse Event Reports (if applicable); correspondence with Sponsor/IEC etc.
• Ensure that the protocol and all trial procedures are being adhered to by the investigator/site staff.
• Ensure that all patients have signed an Informed Consent form prior to their participation in the study;
• Review CRFs and source data (patient medical records, lab reports etc) for completeness and perform source document verification ie. compare CRFs with patient medical records to ensure that the data is accurate and consistent;
• Retrieve or arrange shipping of completed CRFs to Data Management;
• Ensure that Adverse Events have been reported appropriately;
• Visit pharmacy (if appropriate) and perform drug accountability and ensure drug has been stored and dispensed correctly (review documentation);
• Check lab samples (blood/urine) have been taken and handled/shipped/ stored according to instructions provided in the lab manual;
• Resolve data queries with site staff;
• Address any study issues with site staff at each visit ie. protocol violations/deviations; recruitment issues; CRF entry errors/omissions; inadequate source documentation, and work to resolve these.

Close-out Visits:

• Final visit to the site (usually after database closure) to ensure that all study documentation and records are complete (including drug accountability and destruction records; subject identification list; data queries) and arrange for retention/archiving of these on or off-site, (including Investigator File and copies of CRFs), for the required timeframe.
• Ensure patient medical records are labelled to ensure retention by Medical Records.
• Ensure that all CRFs, data queries and unused drug/study supplies have been retrieved.

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