MMG Registry Protocol V1

CARE (Cancer Research Registry) PHILLIPPINES

HOSPITAL-BASED (MMG-Palawan COOP) REGISTRY

PROTOCOL

Protocol Number:_____
Version: ____________
MMG-COOP

Principal Investigator:Dr Joseph M. Tovera

Primary Sponsors:
CARE Philippines
Palawan MMG-COOP Hospital
Medical Staff Organization (MMG-COOP)

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MMG Registry Protocol V1

PROTOCOL

I. Objectives:
The objective of this project is to establish a hospital-based
CancerRegistry at the MMG-Palawan COOP Hospital for the purpose
of:
1. To provide local patient data to a national pool of patient data for a
national cancer registry which is sponsored by the CARE
Philippines. CARE Philippines aims to establish the incidence,
prevalence and mortality rates of cancer in the country.

2. To establish a hospital-based registry for the purpose of

performing retrospective research studies on cancer; such research
involves analyses of the medical record information of patients
seen in the hospital who agree to allow their medical record
information to be included in the registry. 


3. To establish a patient pool who may be eligible for participation in

the future prospective studies to be conducted by the MMG-
MMG-COOP
Palawan COOPresearchers.

Note for objectives 2 and 3, researchers will obtain the permission of the
registry participants to be contacted to ascertain their interest in
participating in future research studies to be conducted for which they
may be eligible. Further, a separate protocol shall be for approval for
any additional studies utilizing the data from this registry in the future.

II. Background and Significance:

There is an increasing cancer incidence and prevalence across the globe,
this trend is also observed in the Philippines where more Filipinos are
being diagnosed of cancer each year. Figures from the national cancer
statistics and epidemiology are provided and based from major cities in
the country because infrastructure for cancer care is established and
sufficient in contrast to rural and provinces. There is a need of
comprehensive understanding about the magnitude of cancer in the
province and in the country at large.
The MMG-Palawan COOP Hospital is in the forefront of cancer care in
the province. Collaboration of local hospitals with other agencies such as
the CARE (Cancer Registry) Philippines will be able to provide a

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MMG Registry Protocol V1

national registry which will establish cancer incidence, prevalence and

cancer outcomes in the country.
Possible outputs from the registry includes incidence and prevalence,
demographics, epidemiologic features, association of risk factors, and
outcomes of cancer treatment

III. Research Design and Methods:

Participation in the registry is limited to placement of the subjects’
identifiable medical information related to their cancer in a research
database and the use of this information for retrospective cancer research
studies, and/or for the identification and recruitment of potential, eligible
subjects for participation in future research studies involving cancer.
1. Patients potential as subjects will be asked to provide their
writteninformed consent to allow their past, current and future
identifiable medical record information related to their cancer to be
placed in the registry.
. a) Patients will be asked to provide their permission for the use of this
information for retrospective
MMG-COOPresearch; such research to be
conducted by the investigators. 


. b) Patients will be asked to provide their permission to allow the

investigators or their representatives (research staff) to review this
information to determine if the patients- participants may be
eligible for participation in future research studies being conducted
by registry investigators. 


. c) Patients will be asked to provide their permission to allow the

research registry staff to contact them (i.e., based on a
determination of their potential eligibility) to ascertain their
interest in participating in future research studies being conducted
by the investigators. 
 Interested registry participants contacted for
possible participation in future research studies being conducted by
the registry investigators will undergo a separate informed consent
process for each such research study. 


2. Participant medical information will be stored electronically within

the registry. Access to participant medical information contained within
the registry will be restricted to registry investigators.Participant medical
record information will be stored in the registrywith a minimum of

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MMG Registry Protocol V1

5years.
3. Participant medical record information contained within the
registry is not allowed to be provided to secondary research
investigators (i.e., research investigators who are not affiliated with
the CARE Hospital and CARE Philippines).

4. Access of investigators to information contained within the

Research Registry for the purpose of determining if the
participants may be eligible for participation in a research study
shall be granted only upon evidence of IRB approval of the
research study for which access is being requested. Access of
investigators to the Research Registry for the purpose of
identifying potential subjects for participation in a research study
shall be documented. 


IV. Human Subjects:

All MMG-Palawan COOP cancer patients are potential participants of
the Cancer registry: 1. Patients of the Cancer Care Center; 2. Non-
Cancer Care Center Patients but are being medically cared of by an
MMG-COOP physician who is a Research Registry Investigator; 3.
MMG-COOP
Neither 1 or 2 but a Cancer Patient of MMG-COOP, interested and
willing to participate after prior approval from the managing physician.
There will be no age limitation to participate. Minor patients shall
require a consent form from a legal guardian or parents prior to their
inclusion. A written consent form is required for Patients >/= 18yeras
old. Patients with limited mental capacity but whose guardians/parents
expressed interest to participate are required to submit appropriate
consent forms prior to their inclusion.
Cancer patients being taken cared of at home (home-based palliative
care) or being seen at an out-patient clinic outside the Palawan MMG-
COOP Hospital by a registry investigator, upon fulfillment of
appropriate consent forms are also potential participants as long as a
verifiable patient chart will be provided. Pregnant patients and prisoners
are also potential participants in the registry.
There are no additional inclusion/exclusion criteria.
The racial, gender and ethnic characteristics of the individuals
approached for participation in this Research Registry shall reflect the
demographics of patients.

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MMG Registry Protocol V1

No individuals shall be excluded from participation in the Research

Registry based on race, ethnicity, gender or HIV status.

Recruitment Procedures:
1. Cancer Care Center Patients:
All patients who are receiving or seeking medical care at the
Cancer Care Center Clinic will be invited to participate in the
registry. All potential participants will be approached by a registry
investigator/physician, or a member of the registry staff and will be
asked to review a copy of the informed consent form. prior to
being seen by a registry investigator.
2. Non-Cancer Care Center Patients:
Participating registry investigators taking care of cancer patients
may invite their patients’participation to the registry. Potential
participant will be referred to the registry Staff for the informed
consent.
3. Interested cancer patients MMG-COOP
not being seen at the Cancer Care Center
or not a patient of any of the registry investigators may discuss
their potential participation with their physician prior to referral to
the registry staff for consent form.

4. Registry investigators will review the informed consent form with

potential participants and address any questions or concerns prior
to obtaining written informed consent for registry participation.
The registry investigators will also address any future questions or
concerns of registry participants.

5. Only the medical record information of patients who have

provided directly their written informed consent for participation
will be placed in the registry.

6. Potential participation of minor patients (<18 years old) will

require a consent form from the patient’s parent or legal guardian.

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MMG Registry Protocol V1

7. The participation of patients who are mentally incapacitated (e.g.,

comatose, unresponsive, stuporous/drowsy, psychiatric disorder,
etc) shall require the consent form of a legal guardian or parent
prior to inclusion in the registry.

V. Database
1. The registry will use an approved and prescribed intranet
database called the CARE App which will be provided by the
CARE Philippines to the MMG-Palawan COOP Hospital (CARE
Hospital) local computer with the minimum specification
requirements.
2. Local database.
The registrar will be responsible to input the needed patient
information to the CARE App. Security and confidentiality of the
information entered to MMG-COOP
the database shall be the primary
responsibility of the registrar and the Information Technology (IT)
Head of the MMG-Palawan COOP Hospital. Completeness,
verifiability and accuracy of patient data entry into the database is
also the responsibility of the registrar. The local database will be
uploaded to the central main server on a daily or weekly basis.
3. National database.
The local registrar in coordination with the local IT Head and the
national IT Head will electronically share the local database to a
national database. The national IT head shall be responsible for the
security and confidentiality of the national database.
4. Anonimization. An automatically assigned patient identifier
(which contains the identifier assigned to the local CARE Hospital
and the patient initials) will be assigned every time a new patient is
entered to the system. All healthcare staff of the MMG-Palawan
COOP Hospital will respect patients’ rights to privacy. The local
registry staff will only upload encrypted data to the main server.
The local registry staff will not allow access by non-data encoders
to individual named registry data unless so permitted by the patient
with a signed relevant informed consent form.

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MMG Registry Protocol V1

VI. Potential Risks of Research Registry Participation:

There are no risks of physical harm associated with participation in the
registry. Potential physical risks are discussed separately upon
participation to future interventional studies (protocol-specific risks).
Participation in the registry does involve the potential risks of a breach
of confidentiality of the medical record information and associated
privacy of the participants. Such risks will be minimized by 1) removing
direct participant identifiers (i.e., names, medical record numbers) from
information stored in the registry; 2) securing, in a separate location, and
limiting access to assigned codesand 3) limiting access to information
contained within the registry to the investigators.
The data and safety monitoring plan for the registry will involve routine
quarterly monitoring by the Principal Investigator of 1) the removal of
direct identifiers from information contained with the registry; 2) the
documentation of investigator access to the registry; 3) the security of
the database linking the registry linkage codes with participant
MMG-COOP
identifiers and the documentation of investigator access to this database;
and 4) any conditions that may negatively impact the confidentiality of
information contained within the registry.
The security of the local data for processing in a national registry
whichis not limited to electronic transfer, analysis, encoding among
others, shall be the responsibility of the national IT person responsible
who is the data privacy officer of the national registry database.
Only when it is necessary, the Principal Investigator must provide
approval for a registry investigator to access the r registry for
retrospective research studies involving the use of Registry information.
The Principal Investigator must also prior approve any access of registry
investigators to the database linking the registry information to
participant direct identifiers. Access of registry investigators to the
registry for the purpose of identifying potential subjects for participation
in a research study shall be granted only upon the provision of
documentation that the IRB has approved the respective research study.
At the time of annual renewal, a list of studies conducted using the
registry will be submitted to the IRB. In addition, any unauthorized
access to medical record information contained within the research

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MMG Registry Protocol V1

registry or to the database linking the registry information to participant

direct identifiers shall be reported to the IRB.

VII. Potential Benefits of Research Registry Participation:

There are no direct benefits associated with participation in the registry.
The use of information contained within the registry for retrospective
research analyses may be of future benefit to cancer patients.
Participants in the registry will be informed of future research studies
involving cancer for which they may be eligible. Participation in a future
research study involving cancer, for which separate informed consent
will be obtained, may offer direct benefit to Research Registry
participants.

VIII. Costs and Payments:

All costs associated with the implementation and maintenance of the
registry shall be supported by the Medical Staff Orgnization, the MMG-
Palawan COOP Hospital and the CARE Philippines. No costs will be
incurred by participants or theirMMG-COOP
health care providers. Patients will not
be remunerated for their participation in the Research Registry.
Future researches may possibly provide honorarium to investigators and
allowances as well as insurances to participating patients which will be
discussed separately and are protocol-specific.

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