Section 1:- Performance Goals
• Goal No 1
ACTIVATE Inspection Readiness at all times during project’s lifecycle
• Description
Fully utilise functionality of ACTIVATE by ensuring system is prospectively and effectively
used to manage site activation Workflows. **************************************************************** Activate compliance:
• Ensure documents % of completed document placeholders have documents uploaded during the current phase of the study: Target >85%. Measured at the last day of each month.
• Ensure all actual dates in ACTIVATE have a planned and baseline date prospectively completed: Target = 100%. Measured at the last day of each month
• Escalate in time if timelines planned in submission and/or activation plan cannot be met due to external reasons or internal conflicting priorities and update Activate as appropriate
Activate must be updated in an ongoing basis (daily if applicable).
Planned and Actual dates must be present for all sites as soon as possible.
Comments must be added re any activity carried out for the site which is related to submission, contracts or CDPs.
Needed documents must be uploaded within the system. Remember: If it’s not tracked is like if it’s not done!
Document completion % for the metrics will be considered depending on the status of the study
Please remember that all sites, for which you know the submission date, must also have an expected CDP approval date. If the data is blank, it means Activate is not fully updated.
ACTIVATE Inspection Readiness at all times during project’s lifecycle (Private)
Employee Evaluation
Comment: I use the ACTIVATE portal on an almost daily basis to check that the system reflects the correct Site Contracted dates, the anticipated CDP Submission dates, and the possible CDP Approval dates. By doing these checks, I am able to stay within the aforementioned timelines and schedules and ready myself for the inspection of the Study and the SSU Team.

• Goal No 2 Data Cleaning
• Description
All data and queries are cleaned resolved in a timely manner Data cleaning:
• SMA to ensure that data queries are resolved on an ongoing basis and NO significant data backlogs occur. All queries are closed within 30 days. .
• SMA proactively reviews their annual vacation plan against the planned DBL dates. Proactively seeks solution when dates conflict.
Data cleaning and query rating:
• Far Exceeds: All data queries actioned and resolved within 30 calendar days
• Exceeds Some: 98 – 99,99% of data queries actioned and resolved within 30 calendar days
• Meets: 95- 97,99% of data queries actioned and resolved within 30 calendar days
• Meets Some: 90-94.99% of data queries actioned and resolved within 30 calendar days
Employee Evaluation
Comment: Currently, I am actively working on the ALPHA Research Study sites in the United States and Canada to resolve the Data Management queries by sending the queries to the Research Site Study Coordinator and later making follow-up phone calls to see whether the queries have been resolved or whether there is any assistance required. I also ensure that all open queries in the INFORM-EDC database for Alpha are resolved within the required time frame in order to keep the metrics in excellent shape. While working on the Alpha database, I also take account of the Database Lock dates and I keep my CRA and Study CTM updated on all these tasks. I also Work with site staff to get access to INFORM-EDC when required.I also follow-up with the Research Site for ePro-Adjudication queries resolution (queries such as MAC, OIRC, HPR, CV, HERC, GI) raised by WCC Team are also dealt with in time, and the tracker in the eRoom is updated weekly to reflect the Adjudication query work flow status which is shared with our Sponsor...the ALPHA by my Study Clinical Trial Manager.
On my OMEGA Research Study sites in US and Canada, I ensure that the Research Sites- Study Coordinator address Data Management queries timely in MEDIDATA RAVE EDC system.I also Work with site staff to get access to RAVE EDC when required.

Goal No 3
First Patient Recruited • Description
• A Site specific recruitment plan to be written for each site
• Reduce the time between SIV and Site ready to recruit to 24 hours. ***************************************************************************************
Site Specific Recruitment Plans
• Site specific recruitment plans are in place, not generic for the study.
• CRA works with the site prior to the SIV to ensure site will proactively identify the first patients they would invite for screening right after the SIV.
Site activation
• CRA will proactively work with the CTL/CTM, CTA to ensure all supplies and access all study systems will be available by the SIV and site can immediately start screening
Employee Evaluation
• Comment: In the OMEGA study, the new research site enrollment is extended so I am actively working with the Study Start-up team on the new site identification process. I also work with already enrolled research site to send us potential site information who may be interested in conducting research. Site Initiation Visits or SIV which are generally telephonic are scheduled routinely once the enrollment process is complete. Also I make sure all those newly enrolled sites receive supplies such as ISF and Patient binders.
Since I am now promoted as Clinical Research Monitor or CRA,I will be visiting these research sites frequently to do SIV task.
• Goal No 4
First Site Initiation Visit (SIV)
• Description
Pre Study Visit (PSV) completion:
• PSV competed within 14 calendar days (CDS) of site approved for PSV. SIV Completion:
• EU and NA - SIVs completed within 14 calendar days (CDS) of Critical Document Package (CDP) approval.

• APAP and LATAM - SIVs completed within 14 calendar days (CDS) of Critical Document Package (CDP) approval.
*********************************************************************************** PSVs
SIVs
• CRA to contact site for potential PSV dates right after site approval for PSV.
• CRA to complete needed trainings as soon as possible
• Phone PSVs should be done with shorter timelines to compensate for potential delays of on-site PSVs
• CRA to follow-up with SSUA/SMA about the planned CDP submission/approval dates.
• CRA to check site availability for SIV proactively around the planned CDP approval date. Pre-book visits with site.
• CRA proactively reviews annual vacation plan against the planned SIV dates. Proactively seeks solution when dates conflict.
PSV Rating:
• Far exceeds: All assigned PSVs completed within 14 CDS of site approved for PSV
• Exceeds : >95-99% completed within 14 CDS of site approved for PSV
• Meets: 90- 95% completed within 14 CDS of site approved for PSV
• Meets some: 85- <90% completed within 14 CDS of site approved for PSV
• Does not meet : < 85% completed within 14 CDS of site approved for PSV SIV Rating:
• Far exceeds: All SIVs completed within 14 (21) CDS from CDP approval of each site
• Exceeds : >95-99% completed within 14 (21) CDS from CDP approval of each site
• Meets: 90- 95% completed within 14 (21) CDS from CDP approval of each site
• Meets some: 85- <90% completed within 14 (21) CDS from CDP approval of each site
• Does not meet : < 85% completed within 14 (21) CDS from CDP approval of each site

Overall rating:
• Far exceeds: Both are exceeds some.
• Exceeds : if one is far exceeds and one exceeds some or both exceed some
• Meets: Both are meet or one exceeds some and meet combination or far exceeds/ exceeds some and meets some combination
• Meets some: Both meet some or combination of meets and meets some or meet and does not meet Employee Evaluation
• Comment: I have done quite a bit of SIV and PSV for my US and Canadian sites exceeding the above said goals .Now that I have been promoted to CRA,SIV and PSV will be done more frequently.
• Goal No 5
First SIV - Deliver Quality CDPs (Critical Document Package)/Activation Plan
• Description
Goal for SMAs performing start up activities
80% accuracy of CDP predictability per month; number of CDPs planned (GoBalto) vs completed per month. Target date to be changed no more than twice in line with contract.
• SMA to prepare site specific activation plans and document the key dates in Activate
• Share site activation plan with site staff and Site Monitor if applicable
• Perform risk assessment of plan and include mitigation actions to keep plan in line with overall project Site Activation Plan
• Set priorities to reduce the final protocol approved – 1st CDP approved timeline and reduce the time between the 1st and last CDP approval
• Work with Site Monitor, if applicable to reduce the time between the CDP approval and SIV
• Site specific plans are regularly revised to reflect the actual situations. How to evaluate this goal:
Since we don’t have site specific activation plan templates/procedures, the following will be evaluated:
• All selected sites must have CDP planned dates in Activate

• The planned dates must be in line with contract and agreed with the CTL. A note must be written on the country comments section in Activate, stating that the planned site activation dates have been agreed with the CTL
• The planned dates can only be changed in exceptional circumstances (i.e. delays at the sponsor’s side). If a date is changed in agreement with the CTL, please document that in the “comments section” in Activate.]
• Remember that delays at the study team side, Legal or the site must be followed up closely in the first instance. If no progress, this must be escalated to the CTL. If no progress after CTL escalation, escalate to your Line Manager.
• If you will not meet a planned date, this must be notified to your CTL in advance in writing. This will demonstrate that you are aware of the Site Activation expected date and are working to achieve it. Depending on the circumstances the CTL may decide to update the Planned date
• All the above must be met for all your sites in order to have a “Meets”. The above items are mandatory and will help you reach your goal:
Employee Evaluation
• Comment: I correctly and very cautiously use the ACTIVATE portal as trained to update CDP baseline and planned dates in conjunction with our SSU and the Site Contract Specialist. I also make sure that I don’t make unnecessary CDP changes, and therefore, I am always on the top with the said team. This is again a challenging role that I have been assigned but one that I thoroughly enjoy. I am very well versed with this system as we move forward on this research study or any other research study.
• Goal No 6
Inspection Readiness - Compliance with WORLDWIDE Clinical Trials CV procedure, Planview Skills, iLearn, Project and client specific training.
• Description
All new starters to prepare WORLDWIDE Clinical Trials CV and update Planview Skills within 4 weeks of employment
All iLearn, Sponsor and study specific training to be completed by the appropriate compliance dates.
Rating:
• Meets: All training, Planview skills and annual CV update completed by due date

• Does not meet: Appearance on non-compliance report, Planview skills and CV update >1-week past due date.
Employee Evaluation
• Comment: I make sure my CV is updated and when I am told to do so as per WORLDWIDE Clinical Trials SOP. All of my training sessions are updated in i-Learn since I ensure that I take them diligently long before the due dates.
• Goal No 7
Inspection Readiness - eTMF Goals for SMA organization: Completeness and Timeliness
>95% at all times • Description
eTMF Goals for SMA organization:
Completeness and Timeliness >95% at all times
Submit TMF documents in 10 business days of receipt/finalization. TMF/ISF reconciliation at least quarterly or as per FMP. ********************************************************************** TMF goal
• TMF and Investigator Site File Reconciliation on an ongoing basis to ensure both are audit ready at all times.
• SMA to review eTMF report regularly and have inaccurate placeholders deleted.
• Ensure all documents received from sites are submitted to the TMF immediately and queries from Document Management are responded to timeously to ensure documents are finalized in the TMF within 35 days of receipt by SMA.
• SMAs to acknowledge that they are the document owners of site specific documents and they are accountable for the quality of those documents and are required to respond to quality related queries from Document Management.
Employee Evaluation
• Comment: This task is not new to me, and I am very well versed with TMF's procedure. Due to my familiarity with the operations and processes, I upload all required documents to TMF and ICO Master within the required time frames.

• Goal No 8
Monitoring Oversight - Follow-up letters sent to site within 10 working days from visit, documented in ICOTrial and filed in TMF. • Description
Follow-up letters sent to site within 10 working days from visit, documented in ICOTrial and filed in TMF.
Visit related expenses submitted within 15 working days from visit date. Rating:
• Meets: >= 95% of Follow-up letters sent to site within 10 working days from visit, documented in ICOTrial and filed in TMF and visit related expenses submitted within 15 working days from visit date.
• Meets Some: >= 90% - <95% of Follow-up letters sent to site within 10 working days from visit, documented in ICOTrial and filed in TMF and visit related expenses submitted within 15 working days from visit date.
• Does not meet: <90% of Follow-up letters sent to site within 10 working days from visit, documented in ICOTrial and filed in TMF and visit related expenses
Employee Evaluation
• Comment: On OMEGA study after performing SIV,PSV and COV(for IVY League Info: these are all different visits and are performed either remotely via WEBEX or on site but till date I have done all remotely via WEBEX) I always ensure that I send Follow-up letter to the site and update the ICOTrial portal(for IVY League info:ICO trial is my company’s database) asap to reflect excellent metrics. As of now, all of the SIVs,PSVs and COVs are remote, and there is no expense report generated because I have done them via WEBEX.Now since I have been promoted as a CRA In the future, there will be a physical site visit for which the expense report will be created, and I have learnt that the task as well just to ensure that I will be ready if I am required to create the report. Any new task to me is self-rewarding since I get to learn new things and challenge myself while at it.
• Goal No 9
Monitoring oversight - Timely resolution of Action Items within 8 weeks
• Description
Timely resolution of Action Items within 8 weeks (56 calendar days).
All CDA findings are actioned within 30 calendar days and resolved within 8 weeks **********************************************************************
Ongoing and resolved action item should be included in the calculation

Rating:
Does not meet <=85% of Action items closed within 8 weeks Central Data Analysis (CDA) findings:
Timely resolution of CDA findings through on-site monitoring visits (SMVs), off-site monitoring visits (OMVs), site management contacts (SMCs), and regular site contacts as outlined per the study’s Monitoring Plan.
Rating:
• Far Exceeds: All CDA findings closed within 30 calendar
• Exceeds Some: 98- 99,99% of CDA findings closed within 30 calendar days
• Meets : 95 - 97,99% of CDA findings closed within 30 calendar days
• Meets Some= 90-94.99 % of CDA findings closed within 30 calendar days
• Does not meet= <90% of CDA findings closed within 30 calendar days
Note: for rating apply the most stringent condition (should be an average)
Employee Evaluation
• Comment: The successful completion of an Action item raised after a Site Monitoring Visit is always rewarding since it is quite a challenging task to make the site complete an open item within a set time frame. On my OMEGA study, I ensure site always completes the assigned task and action items on time. I am glad to report that I have seen the successful completion of action items and assigned tasks on the site. The same happens in my ALPHA study, and as a top priority, I consistently stress on the importance of timely task and action item completion to all the sites that I oversee.
• Goal No 10
Monitoring Oversight - Trip report (TR) is submitted within 5 working days post visit. Trip report finalized within 10 working days from visit, documented in ICOTrial and filed in TMF.
• Description
Trip report (TR) is submitted within 5 working days post visit. Trip report finalized within 10 working days from visit, documented in ICOTrial and filed in TMF.
• Far Exceeds= 100% of Action items closed within 8 weeks 8
• Exceeds some: >= 95% of Action items closed within 8 weeks
• Meets >= 90% of Action items closed within 8 weeks Meets some < 90% of Action items closed within 8 weeks

Rating:
• Meets: >= 95% of trip reports are submitted within 5 working days post visit and finalized within 10 business days post visit
• Meets Some: >= 90% - <95% of trip reports are submitted within 5 working days post visit and finalized within 10 business days post visit
Does not meet: <90% of Trip report submitted within 5 working days post visit and finalized within 10 business days from visit.
Monitoring Oversight - Trip report (TR) is submitted within 5 working days post visit. Trip report finalized within 10 working days from visit, documented in ICOTrial and filed in TMF. (Private)
Employee Evaluation
• Comment: Currently, I am in full compliance with this task and I ensure that after each PSV,SIV and COV I complete monitoring oversight trip report diligently and have met the goals.
• Goal No 11 Monitoring Units
• Description
≥ 8 monitoring units /FTE/month
This goal must be prorated for starters during the year and should apply from month 3 of employment to allow for training and on boarding.
This goal must be prorated for partial FTEs.
Adequate forecasting for future visits within ICO Trial and proactive visit schedule as per MM frequency is an expectation.
**************************************************************************************
Site Management Contact Unit = 0.1
Remote Monitoring Unit = 0.2
On Site Monitoring Unit = 1
Note: The target for this metric is to be prorated to the % FTE dedicated to start up.
CRA actively schedules visits as per MM frequency and actively looks for visit opportunities. For example:
• Volunteers for PSVs
• Volunteers for visits in the region per project need
• Requests additional units if the available time at the visit is not enough to leave the site inspection ready.
• Does not exceed the contracted hours on site /visit unit

• Effectively loops visits whenever possible
• Takes effort to reduce travel time
• Schedules visits 3 months in advance in ICOTrial
Employee Evaluation
Comment: I always try to accomplish the given task as per allotted FTE since I consider myself an old timer at WORLDWIDE Clinical Trials.
Section 2:- Values
• Please detail below your areas of focus for the year ahead
1) Reviewing the study case report forms completed by the investigative sites where clinical trials take place, and verifying entries by validating accurate source documentation to support CRF entries.
2) Documenting site visits and issues in reports and follow-up Letters to the site.
3) Facilitating effective communications among investigative sites, the client, and my company.
4) Responding to the company, client and federal regulatory requirements/audits.
5) Contributing to the project team by mentoring new members, assisting in the preparation of project communications and tools, and sharing ideas and suggestions with team members.
Employee Evaluation
• Comment: My current position as a Clinical Research Monitor to which I was promoted on Sep 30,2019 and my involvement in several projects (ALPHA,OMEGA,Oncology-Mega,Bipolar drugs and Sega) earned me a new appreciation for diligent work and sticking to the deadlines set on the agreed upon timetables and schedules.
I also learned the value of regular reviewing of the set goals since this evaluation helps me accomplish these goals as agreed. Should any changes occur in the project, I plan to modify the following list of goals to meet the new requirements and modify the steps necessary to reach these new goals accordingly. These goals include:
1).Reviewing the study case report forms completed by the investigative sites where clinical trials take place, and the verifying the entries by validating accurate source documentation to support CRF entries.
2). Documenting site visits and issues identified in reports and follow-up Letters sent to the site.
3).Facilitating effective communication among investigative sites, the client, and my company.
4).Responding to the company, client and federal regulatory requirements/audits. 5).Contributing to the project team by mentoring new members, assisting in the preparation of project communications and tools, and sharing ideas and suggestions with team members.
Section 3: - Strengths & Development Areas
Please detail below your areas of focus for the year ahead
Identify the tasks that I will likely to pit off ahead of time, Understand why I have put off a certain task, Use deadlines to motivate myself, and Reward myself as I achieve my goals
Employee Evaluation
• Comment: I believe that one of my greatest strengths lies in task management and scheduling. I have the ability to identify tasks that are more likely to be quickly completed before the deadline and then allocate the time saved to tasks that are pending, or those that have been put off. Additionally, I find my ability to meaningfully understand the reasons for postponing specific tasks a significant strength since it allows me to lower the chances of doing the same thing in the future.
The use of deadlines to keep my work motivation elevated is an additional strength since deadlines puts me under just enough pressure to push me to complete my tasks on time. However, I always try to reward myself when I achieve some of my goals since this gives me new motivation to grow professionally and acquire new skills and competencies.
Since I have been promoted to Clinical Research Associate or CRA I will emphasis on the following topics as listed below
Regardless of the type of visit, when a CRA is at a trial site there are many study- related activities that may occur. Some specific examples of monitoring tasks include:
• Enrollment process and standards. Is the site enrolling qualified participants?
• Informed consent procedure. What process is being used to obtain and manage properly-completed consent forms?
• Protocol adherence. Are any deviations from the protocol taking place?
• Data entry. Is the site entering data completely, accurately, and in a timely manner?
• Medication distribution. Is the site carefully managing and distributing the study medication?
• Regimen compliance. Are subjects complying with the medication regimen that they have been assigned?
• Query response. Does the site answer questions promptly?
• Regulatory compliance. Are the necessary legal and regulatory documents completed correctly and filed?
• Adverse event reporting. Are all adverse events being properly logged and reported? Are serious adverse events being sent to the Institutional Review Board (IRB)? (for IVY League: Pls fix the above comments based on your experience)

• Goal
Section 4:- Development Goals
Gain a more in-depth perspective of how departments with the WORLDWIDE Clinical Trails are run.
• Description
Continuing to learn new skills and practices at any stage in my career. Regular enrolling in i- Learn courses will be an invaluable way to gain skills and knowledge in my role. Gain upward feedback from team members before the end of the quarter to establish further what can be improved upon.
• Relates To
• Category
Knowledge Management & Sharing (Advanced) (Competency)
• Supports
Talent, Leadership Development & Culture
ACTIVATE Inspection Readiness at all times during project’s lifecycle (Private)
Employee Evaluation
• Comment
: As a CRA and as our industry evolves,I will face many new challenges. Reporting is one area where changing expectations are requiring CRAs to adapt. Sponsors increasingly want more visit details in the body of a report, even though the FDA may not require them. This is a change from the past, when sponsors had fewer requirements. Unfortunately, these new requirements can affect efficiency and impact the cost of the trial. I would wish to learn and develop the above skills as I excel being a CRA.The second very important task is to ask or request my company to get me trained or certified in few of the Data Management courses carried out by Medidata RAVE for my Data Learning competencies further since this would improve my speed and efficiency at resolving data queries on an ongoing basis. I believe that improving my knowledge and skills this development goal would help me achieve higher user- satisfaction rates since all queries would be closed within the 30-day period without having significant data backlog losses. I also believe that working on the Goal 2 would help me provide support services better since I would learn to coordinate working and vacation schedules between the Data Backlogs dates and the annual vacation plans.
2019 Overall Performance Summary
Please complete this section giving an overall summary of your performance against your Goals and Competencies for the year. You should include key achievements which you are most proud of and their impact to the business. You should also detail the progress you have made in addressing your areas for development and delivering on your development goals.
Detailed Guidance: Employees must enter an Overall Summary Comment. Managers must enter an Overall Rating and Summary Comment. If the Rating field or Comment field is incomplete, an error message will be received upon submitting the form.
Employee Evaluation
Comment: I highly appreciate WORLDWIDE Clinical Trails giving me an opportunity to spend time learning from their experts and gaining professional skills that I apply regularly. The constant involvement in, and providing inputs for various studies allowed me to witness

first-hand, the way high-quality studies are conducted. I also believe that I made considerable improvement in my attention to detail, and also advanced my communication skills.
I also became a more resolution-oriented and improved my efficiency and thus I have a reason to believe that I am a valuable asset and a respected member of my team. I hope that all of the acquired skills will help my professional development at this company to advance to a higher role. I believe my multi-tasking abilities, as well as my commitment to meet all studies’ deadlines, have earned me appreciation among the team members that work on the same studies as I do. (for IVY League: Pls add more comments based on your experience)

1. Performance Feedback.
Collaborative attitude: When it comes to team work and collaboration, the subject is able to effectively collaborate with project and team members in order to deliver action items and complete project tasks on time. He also demonstrates great willingness to share new ideas with the team, brainstorm on team members’ suggestions, apply best practice techniques, and find new ways of completing tasks efficiently while still complying with the set policies and guidelines. Overall, the employee is a team player who is cooperative, possesses a calm demeanor, works well under pressure and exhibits a harmonious disposition.
Timeliness of deliverables: He has been able to demonstrate effective time management skills by meeting all the required project and team deadlines. He is also punctual and well-prepared for all meetings and takes time to digest all the provided information before making useful contributions. When chairing team meetings, he encourages everyone to make contributions, ensure that discussions do not sway from the set agendas, and that clear records of meeting outcomes, resolutions and action plans are circulated on time. He could improve and con tribute more by looking for innovative methods and techniques of carrying out site management operations especially when it comes to managing query backlogs.
Quality of deliverables: He regularly meets and exceeds all productivity targets set for him and his team at every appraisal and review checkpoint and consistently delivers exceptional high-quality work in all assigned tasks and projects. He also makes significant contributions to the productivity levels of his team through motivation, collaboration and effective communication skills.
Partnership: He is a team player team player who is cooperative, possesses a calm demeanor, works well under pressure and exhibits a harmonious disposition. He combines efforts with team members, senior management and even juniors to chart a development path.
Comment:
In regard to my strengths and development opportunities, I am capable all-round employee who exceeds the company’s quality and productivity expectation expectations for the current job roles and assigned projects. In terms of developmental opportunities, my diligent work

ethic, adherence to schedules and deadlines, and team playing propelled me to a higher role as CRA now and move ahead.
2. Performance Feedback.
Comment:
In terms of the quality of work and productivity, I am a very capable employee who can work on challenging tasks and still deliver error free work in time. I not only hand in deliverables such as TMFs and trip reports on time, but also post great metrics and motivate my team to complete action items and project tasks in a timely manner.
I communicate issues rapidly to my team and given his efficient oversight of the each and every task I am assigned with managing and the results posted, it is evident that I am an effective communicator who can do more if given the opportunity.My response time to issues and day to day task is above average and I post very great turnaround times when it comes to prompt query processing and following up action items till their closure.
Finally, My site management capabilities are excellent and they can be termed as a product of effective team management, great communication skills, disciplined time management, and advanced knowledge and skills in my area of expertise. I am a fast learner who takes challenging tasks as rewarding opportunities, and proceeds to take an initiative to undergo training and acquire new knowledge. Overall, I am is a well-rounded team player and leader who can undertake greater challenges that my current role allows. The new challenging role of a Clinical Research Monitor job to which I was promoted on Sep 30,2019 I will endeavor to do much more.

Section 1:- Performance Goals • Goal No 1 ACTIVATE Inspection Rea...