Professional Documents
Culture Documents
Page 3
Responsibilities of an Investigator
Page 3
Pre-Contact Needs Identifying and Screening
assessment Investigators -
Process Flowchart
Follow-Up Contact
Information is evaluated according to
Basic Investigator Criteria
Page 7
Sources for your search
• Professional Network
• In-house network
• Consultants
• Computerized searches
• Directories
Page 12 - 16
Contacting Potential Investigators-
Initial Contact
• A CRA should explain….
Page 19
Contacting Potential Investigators-
Initial Contact
• A CRA should request information on..
– Investigator qualifications
• Medical training, study experience
– Access to required number of subjects
– Site capability
• Equipment, staff, etc.
– Availability of independent ethic committee
• Frequency of meetings etc.
Page 19
Contacting Potential Investigators-
Follow-Up Contact
• After the confidentiality agreement has been
signed, a CRA can disclose more information,
such as:
• A description of the medicine and the
purpose of the study
• Number and type of subjects
• Length of the study
• Methodology of the study
• Concept of the design of the study
Page 21
Selection Criteria-
Factors to consider
Page 23
Selection Criteria-
Factors to consider
– Training
– Ability and Experience
– Reputation
– Access to suitable subjects
– Concurrent Studies
Page 24 -30
Selection Criteria-
Factors to consider ( cont’d)
– Verification of
Investigator Claims
– Facilities and
Equipment
– Geographic and
Demographics
– Geographic
Distribution
– Site accessibility
Selection Criteria-
Factors to consider ( cont’d)
Page 23- 41
Selection decision-making
• It is the role of the CRA to
provide sufficient
information for a study
team to identify suitable
investigators for the study.
• Your observations and
assessments about the
potential investigators will
be critical in the decision
making process.
Page 45
An Important factor in the success
of a clinical study
• The selection of the
investigator is the first
and most important
factor in the success
of any study.
Page 45
Kuantum CRA Training Program
Welcome to the training session today. The subject this week comes from the
second book in our series. It is “Identifying and Screening Investigators” First, I
suppose we must ask ourselves. “What IS an investigator?”
1
What is an investigator?
An investigator must be qualified by training and
experience..
An poor investigator can waste time, money material and energy. The first step
to a successful clinical study is the careful selection of an investigator
2
Responsibilities of an Investigator
Page 3 3
Now that we know what an investigator IS.. We must ask..What are the
responsibilities of an investigator?
3
Responsibilities of an Investigator
Page 3 4
Of course he must follow the guidelines and regulations laid down in the GCP
4
Pre-Contact Needs Identifying and Screening
assessment Investigators -
Process Flowchart
Follow-Up Contact
Information is evaluated according to
Basic Investigator Criteria
Here is a flowchart detailing the selection process. We will talk about each step.
Firstly the CRA must determine the needs for the particular study.. For example,
how many sites, how many subjects per site.. What kind of medical specialty is
required.. What kind of equipment is needed.. This is the PRE-CONTACT
NEEDS ASSESSMENT.
Next, the CRA begins searching for the investigator through his sources. We will
discuss this in more detail in a second.
The CRA makes an initial contact.. By phone normally. This is a check just to see
if there is any interest at all in conducting a study.
After a confidentiality agreement has been signed, the CRA gives a more
detailed description of the clinical trial. The drug, the purpose of the study, the
methods used..
Then comes the evaluation process. The flowchart lists separately the Basic
Investigator Criteria and the Study Mandated criteria- in fact, this is generally
combined into an overall evaluation.
Now comes the decision making time.
Finally, if everything else is okay, the investigator looks good, he is interested, he
has the staff, the time, the facility and the subjects.. Then he is added to the list
for the pre-study visit.
5
Pre-contact needs assessment
Page 7 6
Now let’s go back to beginning of the flow chart. The Pre-contact needs
assessment. What kinds of things are we looking for in a potential investigator?
What kind of staff requirements? Subjects? Equipment?
Here is a short list of the kinds of things a CRA must research before selecting
and screening an investigator. Every study will have its own requirements and it
is wise idea to consider the special needs before making any contact with
potential investigators.
6
Sources for your search
• Professional Network
• In-house network
• Consultants
• Computerized searches
• Directories
Page 12 - 16 7
7
Contacting Potential Investigators-
Initial Contact
• A CRA should explain….
Page 19 8
After you have compiled a list of potential investigators, your next step is
to contact them. Here are a few things you, as a CRA, would need to
explain to a potential investigator. It is important that you do not reveal too
much information about the details of the trial of the study. This
information is considered confidential and must be closely guarded.
However, here is a list of the some of the information that can be revealed
at this point in the study.
8
Contacting Potential Investigators-
Initial Contact
• A CRA should request information on..
– Investigator qualifications
• Medical training, study experience
– Access to required number of subjects
– Site capability
• Equipment, staff, etc.
– Availability of independent ethic committee
• Frequency of meetings etc.
Page 19 9
There are things about the potential investigator every CRA needs to know right
from the start. His qualifications, what his site can handle, whether he/she has
access to a suitable number of subjects, and whether the investigator has the
support network for a study. A CRA should also consider whether this investigator
will be able to communicate with the independent board of ethic committee.
If the candidate seems interested, he must provide a CV and must sign a
confidentiality agreement. Until this time, there should be no further discussions
about the details of the study.
9
Contacting Potential Investigators-
Follow-Up Contact
• After the confidentiality agreement has been
signed, a CRA can disclose more information,
such as:
• A description of the medicine and the
purpose of the study
• Number and type of subjects
• Length of the study
• Methodology of the study
• Concept of the design of the study
Page 21 10
10
Selection Criteria-
Factors to consider
Page 23 11
11
Selection Criteria-
Factors to consider
– Training
– Ability and Experience
– Reputation
– Access to suitable subjects
– Concurrent Studies
Page 24 -30 12
12
Selection Criteria-
Factors to consider ( cont’d)
– Verification of
Investigator Claims
– Facilities and
Equipment
– Geographic and
Demographics
– Geographic
Distribution
– Site accessibility
13
6. Verification of Investigator Claims- Taking a closer look at the files might reveal
that the investigator’s claims are not based on facts. Does he REALLY have the
right number of subject to begin a study or is he exaggerating the situation?
7. Facilities and Equipment- Interest is one thing but consider the physical site. Is
it up to the standard necessary for this study? Perhaps new equipment will have
to be purchased by the sponsor to make the site effective. A more modern site
might be easier to arrange and so a better choice as a site.
8. Geographic and Demographic Issues – Does this investigator have access to
the types of subjects to match the study protocol?
9. Geographic Distribution- It is important that site represent the large subject
population as a whole. Therefore, widely distributed sites may be more valuable
to the sponsor. A CRA must balance THIS factor with subject access to the site
itself.
10. Site accessibility - Is the facility easy for subjects to reach regularly? If
subjects have trouble reaching the site easily, the study could start off well
enough and then slowly break down over time. This is one reason why an urban
area has certain advantages over a non-urban one.
13
Selection Criteria-
Factors to consider ( cont’d)
Page 23- 41 14
INVESTIGATOR ACCESSIBILTY
Not every doctor may have time to actually conduct a research study although they may be
interested in participating initially. Any potential investigator that refuses to return calls or keep
appointments will NOT make a good candidate.
14
Selection decision-making
• It is the role of the CRA to
provide sufficient
information for a study
team to identify suitable
investigators for the study.
• Your observations and
assessments about the
potential investigators will
be critical in the decision
making process.
Page 45 15
The decision making process is a matter of teamwork among the study team. On
the other hand, your own subjective observations and assessments regarding
the potential investigator can make the entire research process much easier.
15
An Important factor in the success
of a clinical study
• The selection of the
investigator is the first
and most important
factor in the success
of any study.
Page 45 16
For this reason, identifying the RIGHT investigator for your study is the first step
for a successful clinical research project. This concludes the presentation. If you
have any questions, I will do my best to answer them. Thank you
16
Kuantum CRA Training Program
17
Thank you very much for your attention- if you have any questions about the
subject, please feel free to ask.
17
Activity
18
19
Here is the CV for Dr. Aorta. Let’s examine this carefully together.
What is this doctor’s specialty? Tell me about some of his published research?
19
20
Here is the qualification visit report filed by the CRA. In the book, this would be
the follow-up for the initial contact. The description for each of the visits
somewhat overlap from the book to our experience. However, it is more
important to know the function of the visits. The names may change.
Anyway, let us see what the CRA has found out about Dr. Aorta. Hmm.. Line 12
is negative.
20
21
21
22
23
24
24
25
25
26
27
28