Well done! (Answer: D) The Foundation is interested in an evaluation of the research capacity building activity – Maria’s GCP workshop. Although the performance of the 50 participants might well be relevant to that evaluation, it is just a part of what Maria may include in her analysis. The training may – at least hopefully – have an impact on the Phase III trial by preparing staff members to participate, but that is not what Maria will be evaluating here.

Incorrect. (Correct Answer: D) The Foundation is interested in an evaluation of the research capacity building activity – Maria’s GCP workshop. Although the performance of the 50 participants might well be relevant to that evaluation, it is just a part of what Maria may include in her analysis. The training may – at least hopefully – have an impact on the Phase III trial by preparing staff members to participate, but that is not what Maria will be evaluating here.

Well done! (Answer: A + D) Both faculty teaching time and the curriculum are resources used to conduct the training – what we call inputs. Depending on the structure of the evaluation and other data available, the work of the 50 participants could certainly be included to assess the outcomes and impact of the training, but it is not an input to the workshop. The vaccine is not part of the GCP workshop.

Incorrect. (Correct Answer: A + D) Both faculty teaching time and the curriculum are resources used to conduct the training – what we call inputs. Depending on the structure of the evaluation and other data available, the work of the 50 participants could certainly be included to assess the outcomes and impact of the training, but it is not an input to the workshop. The vaccine is not part of the GCP workshop.

Well done! (Answer: B) Increased staff capacity describes the change that Maria, the Institute for Research, and The Foundation want to see as a result of conducting the GCP workshop. It represents a change or effect that we call an outcome. Again, just as when defining indicators for outputs, it is important to think of how to assess if outcomes have been achieved using measurable variables. What about future funding from The Foundation? Is this an outcome of the activity? After all, The Foundation has made clear that there may be a possibility of additional funding if all goes well. Future funding might be connected to the workshop going well, but it is not a result of the activity itself.

Incorrect. (Correct Answer: B) Increased staff capacity describes the change that Maria, the Institute for Research, and The Foundation want to see as a result of conducting the GCP workshop. It represents a change or effect that we call an outcome. Again, just as when defining indicators for outputs, it is important to think of how to assess if outcomes have been achieved using measurable variables. What about future funding from The Foundation? Is this an outcome of the activity? After all, The Foundation has made clear that there may be a possibility of additional funding if all goes well. Future funding might be connected to the workshop going well, but it is not a result of the activity itself.

Well done! (Answer: B) The list of certificates could serve Maria’s purposes here. She can simply count how many pass certificates are issued – using them as a data source for this output indicator. The number of GCP-certified staff members working on the trial might not work because there may be staff that were already trained.

Incorrect. (Correct Answer: B) The list of certificates could serve Maria’s purposes here. She can simply count how many pass certificates are issued – using them as a data source for this output indicator. The number of GCP-certified staff members working on the trial might not work because there may be staff that were already trained.

Well done! (Answer: C) Hiring more staff members is probably not directly related to the GCP workshop. On the other hand, expanding The Institute into a regional centre for clinical trials, and even reducing the impact of infectious diseases of poverty are probably much too big and long-term to reasonably connect to the GCP training as a short- to medium-term objective.

Incorrect. (Correct Answer: C) Hiring more staff members is probably not directly related to the GCP workshop. On the other hand, expanding The Institute into a regional centre for clinical trials, and even reducing the impact of infectious diseases of poverty are probably much too big and long-term to reasonably connect to the GCP training as a short- to medium-term objective.

Well done! (Answer: A + B) We will talk more about how we can interpret “impact” in the context of research capacity building activities during the face-to-face training, but it is important to understand that here we can choose to define the impact level population at the institution level (rather than the general population we might use in a different context). With that in mind, training staff members is part of Maria’s plan for the activity, but it is not a high-level institutional goal (even if it is aligned with at least one, and probably more than one). The eighty-percent guideline came from The Foundation, but it is related to the immediate products or deliverables of the training – again, not a high-level goal. Both A. and B. are big, institutional goals that could be aligned with developing staff capacity.

Incorrect. (Correct Answer: A + B) We will talk more about how we can interpret “impact” in the context of research capacity building activities during the face-to-face training, but it is important to understand that here we can choose to define the impact level population at the institution level (rather than the general population we might use in a different context). With that in mind, training staff members is part of Maria’s plan for the activity, but it is not a high-level institutional goal (even if it is aligned with at least one, and probably more than one). The eighty-percent guideline came from The Foundation, but it is related to the immediate products or deliverables of the training – again, not a high-level goal. Both A. and B. are big, institutional goals that could be aligned with developing staff capacity.

Well done! (Answer: B) Typically, an evaluation looks at what has been achieved by a specific activity, and a significant part of the analysis will occur once the activity is complete. Maria might have a very clear perspective on this, and her personal views (along with the views of other stakeholders, like the participants and her director) could well be relevant, but a well-structured evaluation will include measurable indicators and multiple data sources. By the same token, the final examination may be somehow relevant to the evaluation, but that is not what The Foundation is asking for here.

Incorrect. (Correct Answer: B) Typically, an evaluation looks at what has been achieved by a specific activity, and a significant part of the analysis will occur once the activity is complete. Maria might have a very clear perspective on this, and her personal views (along with the views of other stakeholders, like the participants and her director) could well be relevant, but a well-structured evaluation will include measurable indicators and multiple data sources. By the same token, the final examination may be somehow relevant to the evaluation, but that is not what The Foundation is asking for here.

Well done! (Answer: C) Participants who pass the workshop in GCP is a clear product of the activity – what we call an output. The number of participants who pass the training could be a way to capture this output as a variable called an indicator. Indicators should be measurable – that means that they are generally expressed as numbers. The number of future workshops offered by the Institute with funding from The Foundation could perhaps be used in some way to assess outcomes or impact, but from a practical perspective, Maria probably will not see any of this happen before she needs to turn in her evaluation report.

Incorrect. (Correct Answer: C) Participants who pass the workshop in GCP is a clear product of the activity – what we call an output. The number of participants who pass the training could be a way to capture this output as a variable called an indicator. Indicators should be measurable – that means that they are generally expressed as numbers. The number of future workshops offered by the Institute with funding from The Foundation could perhaps be used in some way to assess outcomes or impact, but from a practical perspective, Maria probably will not see any of this happen before she needs to turn in her evaluation report.

Well done! (Answer: C) Maria could turn to a pre- and post-training evaluation as a data source for measuring this outcome indicator. Now she can better understand the change that comes about because of her training activity. It is important that she is developing this M&E Framework alongside the workshop because now Maria can develop and conduct the pre-training evaluation before the workshop starts. Without that step, there is no baseline and she will not be able to measure the change in adherence to GCP. Here, it is important to remember that the list of participants that pass the course is related to the output, not the outcome. It is a bit more complex to measure the results or effects that the workshop achieves.

Incorrect. (Correct Answer: C) Maria could turn to a pre- and post-training evaluation as a data source for measuring this outcome indicator. Now she can better understand the change that comes about because of her training activity. It is important that she is developing this M&E Framework alongside the workshop because now Maria can develop and conduct the pre-training evaluation before the workshop starts. Without that step, there is no baseline and she will not be able to measure the change in adherence to GCP. Here, it is important to remember that the list of participants that pass the course is related to the output, not the outcome. It is a bit more complex to measure the results or effects that the workshop achieves.