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Kuantum CRA Training Program

Lesson 2- Identifying and


Screening Investigators
What is an investigator?
An investigator must be qualified by training and
experience..

An investigator must have


adequate resources to
conduct the study.
Responsibilities of an Investigator

Obtains Institutional Review Board/Independent Ethics


Committee approval of study protocol

Enrolls the required number of qualified subjects and


obtains their informed consent

Administers the test drug

Observes and measures the effects of the study drug

Page 3
Responsibilities of an Investigator

Complies with all procedures specified by the protocol

Records all data important to the study

Follows the regulations and GCP guidelines

Evaluates and manages Adverse Events

Page 3
Pre-Contact Needs Identifying and Screening
assessment Investigators -
Process Flowchart

Begin Search for Potential


Investigator

Initial Contact with Confidentiality


Investigator Agreement

Follow-Up Contact
Information is evaluated according to
Basic Investigator Criteria

Study Team assesses the


Information is evaluated according to potential investigator and
Study-Mandated Criteria decides inclusion or
exclusion from study

The collected information passes to the


Investigator name
pre-study or qualifying visit stage of the
and contact info is
clinical research process
added to list for
pre-study visit
Pre-contact needs assessment

• The total number of investigators


• The level of experience
• The specialization of the investigator
• Facility specialization
• Number of subjects required
• Geographic preferences of study sites
• Expected costs per investigator

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….

– The name and a brief explanation of the


study
– Objectives of the study
– Type and number of subjects
– Length of the study

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

• Study Mandated Criteria


– Requirements from the study
protocol

• Basic Investigator Criteria


– objective information
– subjective impressions

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)

– Time and Cost Factors


– Quality of Staff
– Personal traits of the
investigator
– Investigator
accessibility

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

Lesson 2- Identifying and


Screening Investigators
Prepared by Miacheal Morgan 2007
Activity
Kuantum CRA Training Program

Lesson 2- Identifying and


Screening Investigators

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 investigator must have


adequate resources to
conduct the study.
2

The sponsor is responsible for selecting qualified investigators to conduct clinical


studies of a new and marketable drug. Investigators may be research physicians
connected to medical schools or teaching hospitals or they may be doctors.
BUT, they should be qualified by training and experience with adequate
resources to conduct the study.

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

Obtains Institutional Review Board/Independent Ethics


Committee approval of study protocol

Enrolls the required number of qualified subjects and


obtains their informed consent

Administers the test drug

Observes and measures the effects of the study drug

Page 3 3

Now that we know what an investigator IS.. We must ask..What are the
responsibilities of an investigator?

1. Any clinical trial must be approved by a local ethics committee. An


investigator must obtain this approval of the study protocol
2. he must find the correct number of subjects for the trial
3. It is the investigator’s job to make sure that all the consent forms are
correctly filled out and the subjects have been fully informed of the benefits
and risks of the study.
4. Naturally it is the investigator’s job to administer the new drug according to
the protocol.
5. The investigator must observe and measure the effects of the study drug

3
Responsibilities of an Investigator

Complies with all procedures specified by the protocol

Records all data important to the study

Follows the regulations and GCP guidelines

Evaluates and manages Adverse Events

Page 3 4

He must follow the sponsor’s protocol

He must record all necessary information for the study

Of course he must follow the guidelines and regulations laid down in the GCP

He must evaluate and manage possible Adverse Events

4
Pre-Contact Needs Identifying and Screening
assessment Investigators -
Process Flowchart

Begin Search for Potential


Investigator

Initial Contact with Confidentiality


Investigator Agreement

Follow-Up Contact
Information is evaluated according to
Basic Investigator Criteria

Study Team assesses the


Information is evaluated according to potential investigator and
Study-Mandated Criteria decides inclusion or
exclusion from study

The collected information passes to the


Investigator name
pre-study or qualifying visit stage of the
and contact info is
clinical research process
added to list for
pre-study visit
5

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

• The total number of investigators


• The level of experience
• The specialization of the investigator
• Facility specialization
• Number of subjects required
• Geographic preferences of study sites
• Expected costs per investigator

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

Where do CRAs find potential investigators? Usually, it is necessary to use a


variety of sources.
There are a variety of ways and some of them are listed here as well as in your
book. I wont go into too much detail about the sources for finding the
investigators but for more information about these sources, check pages 12- 16
of your book.

7
Contacting Potential Investigators-
Initial Contact
• A CRA should explain….

– The name and a brief explanation of the


study
– Objectives of the study
– Type and number of subjects
– Length of the study

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

A confidentiality agreement is a legal document in which the potential


investigator promises not reveal the details of the study. A sponsor needs to
know that details about the study will not be revealed, discussed and debated
before the results can be determined.
After the agreement has been signed, the CRA can disclose more information
about the study. Here is a list of the things that a CRA can openly discussed
AFTER the confidentiality agreement has been signed.

10
Selection Criteria-
Factors to consider

• Study Mandated Criteria


– Requirements from the study
protocol

• Basic Investigator Criteria


– objective information
– subjective impressions

Page 23 11

There are two types of information to consider when evaluating a potential


investigator. First, Study Mandated Criteria or what is required from the sponsor
( from the protocol). The right facilities and equipment for example, or access to
suitable subjects for the particular study..

Secondly, personal information gather from the CRA, such as subjective


impressions ( i.e. honesty and interest) Basic Investigator Criteria are traits
that we would expect from ANY investigator, regardless of the needs of a
particular study. For example, honesty, willingness to cooperate, ability to
communicate and a proper amount of time and a bit of skill for management.

11
Selection Criteria-
Factors to consider

– Training
– Ability and Experience
– Reputation
– Access to suitable subjects
– Concurrent Studies

Page 24 -30 12

When collecting information about a potential investigator, there are many


factors to consider. Here is a general list.
1. Training- does the investigator’s CV indicate that he\she has the suitable
medical background or education and training for the study?
2. Ability and Experience – does the candidate has experience with the drug or
the disease? Has the investigator had any experience with drug studies?
3. Reputation – A examination into the investigator’s professional activities, his/
her publication or participation in medical societies may give you a better idea
about the investigator’s ability to handle a study.
4. Access to Subjects – Can the investigator find a sufficient number of
subjects to make the study effective?
5. Concurrent Studies – Is the investigator working on other studies? This is
generally a negative factor. After all, how much attention can the investigator
give to each of his responsibilities?

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)

– Time and Cost Factors


– Quality of Staff
– Personal traits of the
investigator
– Investigator
accessibility

Page 23- 41 14

TIME and COST FACTORS:


As the book states, normally a sponsor does not choose a site only on basis of time factors alone
but it will influence the decision in part. A CRA should study:
1. The date the study would begin at the site. 2. How long will it take to enroll the right number of
subjects 3. The length of time for the study and finally 4. The time it will take for the ethics
committee to approve of the study
Cost factors can also play a role in the decision. Sponsors offer financial support based on the
amount per subject. The rate of pay is the same for each investigator because, after all,
investigators may compare notes. However, site –related costs are usually requested from the
sponsor and costs can vary from site to site.

THE QUALITY OF THE STAFF


The investigator will, of course, need a support team to assist in the study. The quality of the
support team at the site will affect the smooth running of the study. A high turn-over rate, that
is, if the staff changes frequently, a CRA might re-consider the site. It could mean
dissatisfaction at some level within the department and this could ultimately spell trouble for
the study.

PERSONAL TRAITS OF THE INVESTIGATOR


Perhaps it should go without mentioning but the character of the investigator is a important factor.
This may not be so easy to judge over a short time but any sign at an early stage should be
taken seriously.

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

Lesson 2- Identifying and


Screening Investigators
Prepared by Miacheal Morgan 2007

17

Thank you very much for your attention- if you have any questions about the
subject, please feel free to ask.

17
Activity

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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.

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21

Look at line 29 and 30.

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22
23
24

Here is the CV for Dr. Bypass Where is he presently working?

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25

Here is the report from the CRA regarding Dr. Bypass.

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