Transcript Subject Management SOP Presentation

CMRSC
Division of Hematology/Oncology
Training
Standard Operating Procedures for
Good Clinical Practice at the
Investigative Site
Section:
SUBJECT MANAGEMENT –
Topics other than Informed Consent
CMRSC 4.1 –
Subject Recruitment and Screening
Purpose:
To describe the steps for fulfilling the regulatory and
clinical requirements involved in subject recruitment
and selection.
The recruitment phase of a clinical study is frequently
difficult and challenging. Successfully recruiting
subjects involves the development and
implementation of a well-coordinated plan that may
require the efforts of the entire research team. Once
in place, subject recruitment efforts may be constantly
assessed, with new strategies implemented as
necessary. After potential subjects have been
identified through recruitment efforts, the process of
subject selection begins.
CMRSC 4.1 –
Subject Recruitment and Screening
Develop and implement an overall recruitment plan:
1. Based upon the specific inclusion/exclusion criteria for
a study, identify the target population for potential study
subjects.
2. Establish a recruitment timeline.
3. Identify sources of potential participants.
4. Determine recruitment methods (newspaper/radio ads,
letters, community talks, newspaper articles, patient
support groups, Internet).
5. Develop recruitment materials (including screening
tools) and submit to the IRB as appropriate.
6. Project costs and hire staff as appropriate.
7. Monitor progress and assess results of the recruitment
strategies. Submit changes to the IRB as required.
CMRSC 4.1 –
Subject Recruitment and Screening
Initiate screening procedures:
1. Develop a screening log based upon the study
inclusion/exclusion criteria to collect screening
information on all potential subjects.
Job aid! Screening and Enrollment Log
2. Obtain informed consent prior to screening.
Maintain a log of when informed consent was
obtained from each subject.
3. Retain all signed informed consent forms from
subjects who terminate their participation in the
study during the screening process.
CMRSC 4.2 –
Subject Management While On-Study
Purpose:
To describe the steps for fulfilling the regulatory and
clinical requirements to ensure adherence to study
procedures for the evaluation of a subject’s response
to the investigational agent.
Through close monitoring and careful assessment of
subjects, adverse events can be detected early and
treated appropriately. By following these procedures,
close attention is paid to subject well-being and to
integrity of the data.
CMRSC 4.2 –
Subject Management While On-Study
Definition:
Adverse Event (AE): An AE is any untoward medical
occurrence in a patient or clinical investigation subject
administered a pharmaceutical product and that does
not necessarily have a causal relationship with this
treatment. An AE can therefore be any unfavorable
and unintended sign (including an abnormal
laboratory finding), symptom, or disease temporally
associated with the use of a medicinal
(investigational) product, whether or not related to the
medicinal (investigational) product.
CMRSC 4.2 –
Subject Management While On-Study
Enrollment assessments and management:
Obtain prior to enrollment in the study:
a. Informed consent (ensure required study
procedures and visits are thoroughly explained).
b. Medical history and physical exam
c. Baseline signs and symptoms
d. Current medications
e. Collect specimens as required by the protocol
f. Order tests/procedures as required by the protocol
g. Provide contact information to the subject
h. Schedule follow-up visits.
i. Complete required enrollment documentation,
signed by Investigator before actual enrollment.
CMRSC 4.2 –
Subject Management While On-Study
Follow-up, completion, and early termination from the
study:
1. Perform physical exam
2. Assess subject for signs and symptoms of illness,
document adverse events
3. Collect specimens as directed by protocol
4. Order tests and procedures as necessary
5. Institute appropriate therapy if required by the subject’s
condition
6. Review any use of concomitant medications
7. Schedule follow-up visits per protocol
8. Assess the subject’s compliance with test article
9. Collect any unused test article, or dispense additional
test article, as necessary.
CMRSC 4.2 –
Subject Management While On-Study
Communication with primary or referring medical
providers:
1. Inform the subject’s primary care provider
about the subject’s progress while on study, if
the subject agrees.
2. Confer with the primary care provider, as
needed.
CMRSC 4.2 –
Subject Management While On-Study
Management of ineligible subjects:
1. Document the reason for ineligibility/
discontinuation on study. Retain any
supporting data available.
2. Collect any unused test article and any used
test article containers, record data in the
investigational drug log.
3. Investigator should discuss treatment
alternatives with the subject.
4. Notify the sponsor as required.
CMRSC 4.3 –
Adverse Event Reporting
Purpose:
To describe the responsibilities of the research team for
managing, reporting, and documenting adverse
events from the time an adverse event is identified
until all follow-up activities associated with its
resolution have been completed. This procedure also
describes the mechanisms used to provide the
information necessary for sponsors to prepare
Investigational New Drug (IND) safety reports.
Finally, the procedures for processing and
transmitting IND safety reports received from the
sponsor to the IRB are defined.
CMRSC 4.3 –
Adverse Event Reporting
Definitions:
1.
2.
3.
4.
Adverse Event – previously defined
Serious Adverse Drug Experience – Any experience
that results in death, in a life-threatening adverse drug
experience, inpatient hospitalization or prolongation of
hospitalization, a persistent or significant disability or
incapacity, or congenital anomaly
“Associated with the use of the drug” – There is a
reasonable possibility that the experience may have
been caused by the drug.
Disability – A substantial disruption of a person’s ability
to conduct normal life functions.
CMRSC 4.3 –
Adverse Event Reporting
Managing adverse events:
1. Follow up appropriately when a research
subject experiences any adverse change from
baseline or pretreatment condition, ensuring all
appropriate resources are directed toward
subject safety and well-being. Follow the
subject until the event is resolved.
Job aid! Procedures for Managing Adverse Events
2. If necessary for the immediate medical care of
the subject, break the drug blind after
consultation (if possible) with the sponsor.
CMRSC 4.3 –
Adverse Event Reporting
Managing adverse events (cont.):
If the adverse event is serious and/or unexpected,
as per protocol, inform the sponsor as soon as
possible after the subject is stabilized. Provide
as much information as is available.
Job aid! MedWatch Forms FDA 3500 & 3500a
Job aid! AdEERS Reporting system for NCI
1. Record the details of the adverse event in the
source documentation and complete the
appropriate CRFs.
2. Keep photocopies of all relevant
documentation, including fax confirmations,
and file in the study binder.
CMRSC 4.3 –
Adverse Event Reporting
Handling IND safety reports from sponsors:
1.
2.
Promptly review IND safety reports received from
sponsors.
File IND safety reports in the study regulatory file.
Reporting to the IRB:
1.
1.
2.
Notify the IRB of all serious or alarming events
occurring during the approval period for the ongoing
study.
Job aid! CCHMC IRB Adverse Event Form
Promptly submit all IND safety reports received from
the sponsor.
Report to the IRB all routine adverse events as part of
the periodic or annual reporting requirements.
CMRSC 4.4 –
Specimen Collection and Handling
Purpose:
To describe the steps for fulfilling the regulatory and
clinical requirements involved in specimen collection
and handling
The proper collection and processing of specimens
obtained from study subjects are part of the data
collected in a clinical trial. The specimens provide
important information about the drug’s action within
the body and subject’s biologic and clinical response.
To ensure accurate data, specimens must be
collected at the specified time points, processed,
possibly preserved, and then shipped appropriately.
Additionally, research or other staff must adhere to
good laboratory practices when collecting, processing
and arranging for shipment of the specimens to the
testing laboratory.
CMRSC 4.4 –
Specimen Collection and Handling
Collecting the specimens:
1. Observe all OSHA and CCHMC
procedures for infection control when
handling bodily fluids.
2. Collect the specimens identified in the
protocol.
3. Note the date and time of collection.
4. Label test tubes or other containers with
subject identifiers, date, time, and any
other information required per protocol.
CMRSC 4.4 –
Specimen Collection and Handling
Processing the specimens:
1. Process the specimen according to the
protocol (for example, centrifuge speed,
duration, temperature).
2. Separate and transfer the specimen to the
appropriate transport tube(s), as required.
3. Label the study-specific tubes or other
containers as required.
4. Complete the laboratory requisition slip.
Include original in the shipment. Retain
once copy and file in the study binder.
CMRSC 4.4 –
Specimen Collection and Handling
Preparing the specimens for shipping to the testing
laboratory:
1. Prepare and package the specimens according
to federal and state regulations and shipping
instructions specified in the protocol.
2. Complete a specimen shipping log.
3. Retain a copy of the shipping receipt and file in
the subject’s study binder.
4. Track the specimen’s destination arrival, print
and file arrival verification in the subject’s study
binder.
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