STANDARD OPERATING PROCEDURE: Dr XXXXX Site

Title: Standard operating procedure of site activities

SOP No.: GEN-01 Version No.: 01 Effective Date: dd-mmm-yyyy

Author:

__________________________________________________
Name

__________________________________________________ ____________________
Signature Date

Authorised by:

__________________________________________________
Name

__________________________________________________
Title

__________________________________________________ ____________________
Signature Date

PURPOSE

This SOP describes the process to ensure that all activities performed at Dr. ABC XYZ site
under Clinical Trials are performed in a consistent manner.

SCOPE

This SOP applies to all the site members of Dr. ABC XYZ site.

DEFINITIONS/ABBREVIATIONS

Adverse Event (AE)

Any untoward medical occurrence in a patient or clinical investigation subject administered a
pharmaceutical product and which does not necessarily have a causal relationship with this
treatment. An adverse event (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 (see the ICH Guideline for Clinical Safety Data Management:
Definitions and Standards for Expedited Reporting).
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Applicable Regulatory Requirement(s)

Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational
products.

Approval (in relation to Institutional Review Boards)

The affirmative decision of the SITE EC/IRB that the clinical trial has been reviewed and may
be conducted at the institution site within the constraints set forth by the SITE EC/IRB, the
institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.

Audit
A systematic and independent examination of trial related activities and documents to
determine whether the evaluated trial related activities were conducted, and the data were
recorded, analyzed and accurately reported according to the protocol, sponsor's standard
operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory
requirement(s).

Blinding/Masking
A procedure in which one or more parties to the trial are kept unaware of the treatment
assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-
blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data
analyst(s) being unaware of the treatment assignment(s).

Case Report Form (CRF)

A printed, optical, or electronic document designed to record all of the protocol required
information to be reported to the sponsor on each trial subject.

Clinical Trial/Study
Any investigation in human subjects intended to discover or verify the clinical,
pharmacological and/or other pharmacodynamic effects of an investigational product(s),
and/or to identify any adverse reactions to an investigational product(s), and/or to study
absorption, distribution, metabolism, and excretion of an investigational product(s) with the
object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are
synonymous.

Clinical Trial/Study Report

A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent
conducted in human subjects, in which the clinical and statistical description, presentations,
and analyses are fully integrated into a single report (see the ICH Guideline for Structure
and Content of Clinical Study Reports).

Compliance (in relation to trials)

Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements,
and the applicable regulatory requirements.

Confidentiality
Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary
information or of a subject's identity.

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Contract
A written, dated, and signed agreement between two or more involved parties that sets out
any arrangements on delegation and distribution of tasks and obligations and, if appropriate,
on financial matters. The protocol may serve as the basis of a contract.

Direct Access
Permission to examine, analyze, verify, and reproduce any records and reports that are
important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory
authorities, sponsor's monitors and auditors) with direct access should take all reasonable
precautions within the constraints of the applicable regulatory requirement(s) to maintain the
confidentiality of subjects' identities and sponsor’s proprietary information.

Documentation
All records, in any form (including, but not limited to, written, electronic, magnetic, and
optical records, and scans, x-rays, and electrocardiograms) that describe or record the
methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.

Essential Documents
Documents which individually and collectively permit evaluation of the conduct of a study
and the quality of the data produced (see 7. Essential Documents for the Conduct of a
Clinical Trial).

Good Clinical Practice (GCP)

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses,
and reporting of clinical trials that provides assurance that the data and reported results are
credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are
protected.

Independent Ethics Committee (IEC)

An independent body (a review board or a committee, institutional, regional, national, or
supranational), constituted of medical professionals and non-medical members, whose
responsibility it is to ensure the protection of the rights, safety and well-being of human
subjects involved in a trial and to provide public assurance of that protection, by, among
other things, reviewing and approving / providing favourable opinion on, the trial protocol, the
suitability of the investigator(s), facilities, and the methods and material to be used in
obtaining and documenting informed consent of the trial subjects.
The legal status, composition, function, operations and regulatory requirements pertaining to
Independent Ethics Committees may differ among countries, but should allow the
Independent Ethics Committee to act in agreement with GCP as described in this guideline.

Informed Consent
A process by which a subject voluntarily confirms his or her willingness to participate in a
particular trial, after having been informed of all aspects of the trial that are relevant to the
subject's decision to participate. Informed consent is documented by means of a written,
signed and dated informed consent form.

Inspection
The act by a regulatory authority (ies) of conducting an official review of documents,
facilities, records, and any other resources that are deemed by the authority (ies) to be
related to the clinical trial and that may be located at the site of the trial, at the sponsor's
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and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed

appropriate by the regulatory authority(ies).

Institution (medical)
Any public or private entity or agency or medical or dental facility where clinical trials are
conducted.

Institutional Review Board (SITE EC)

An independent body constituted of medical, scientific, and non-scientific members, whose
responsibility is to ensure the protection of the rights, safety and well-being of human
subjects involved in a trial by, among other things, reviewing, approving, and providing
continuing review of trial protocol and amendments and of the methods and material to be
used in obtaining and documenting informed consent of the trial subjects.

Investigational Product (IP)

A pharmaceutical form of an active ingredient or placebo being tested or used as a reference
in a clinical trial, including a product with a marketing authorization when used or assembled
(formulated or packaged) in a way different from the approved form, or when used for an
unapproved indication, or when used to gain further information about an approved use.

Investigator
A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by
a team of individuals at a trial site, the investigator is the responsible leader of the team and
may be called the principal investigator.

Investigator's Brochure
A compilation of the clinical and nonclinical data on the investigational product(s) which is
relevant to the study of the investigational product(s) in human subjects (see 7.
Investigator’s Brochure).

Monitoring
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted,
recorded, and reported in accordance with the protocol, Standard Operating Procedures
(SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

Monitoring Report
A written report from the monitor to the sponsor after each site visit and/or other trial-related
communication according to the sponsor’s SOPs.

Multicentre Trial
A clinical trial conducted according to a single protocol but at more than one site, and
therefore, carried out by more than one investigator.

Nonclinical Study
Biomedical studies not performed on human subjects.

Protocol
A document that describes the objective(s), design, methodology, statistical considerations,
and organization of a trial. The protocol usually also gives the background and rationale for

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the trial, but these could be provided in other protocol referenced documents. Throughout
the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.

Protocol Amendment
A written description of a change(s) to or formal clarification of a protocol.

Quality Assurance (QA)

All those planned and systematic actions that are established to ensure that the trial is
performed and the data are generated, documented (recorded), and reported in compliance
with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

Quality Control (QC)

The operational techniques and activities undertaken within the quality assurance system to
verify that the requirements for quality of the trial-related activities have been fulfilled.

Randomization
The process of assigning trial subjects to treatment or control groups using an element of
chance to determine the assignments in order to reduce bias.

Regulatory Authorities
Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory
Authorities includes the authorities that review submitted clinical data and those that conduct
inspections (see 1.29). These bodies are sometimes referred to as competent authorities.

Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)
Any untoward medical occurrence that at any dose:
• results in death,
• is life-threatening,
• requires inpatient hospitalization or prolongation of existing hospitalization,
• results in persistent or significant disability/incapacity,
or
• is a congenital anomaly/birth defect
(see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for
Expedited Reporting).

Source Data
All information in original records and certified copies of original records of clinical findings,
observations, or other activities in a clinical trial necessary for the reconstruction and
evaluation of the trial. Source data are contained in source documents (original records or
certified copies).

Source Documents
Original documents, data, and records (e.g., hospital records, clinical and office charts,
laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy
dispensing records, recorded data from automated instruments, copies or transcriptions
certified after verification as being accurate copies, microfiches, photographic negatives,
microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the
laboratories and at medico-technical departments involved in the clinical trial).

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Sponsor
An individual, company, institution, or organization which takes responsibility for the
initiation, management, and/or financing of a clinical trial.

Standard Operating Procedures (SOPs)

Detailed, written instructions to achieve uniformity of the performance of a specific function.

Subinvestigator
Any individual member of the clinical trial team designated and supervised by the
investigator at a trial site to perform critical trial-related procedures and/or to make important
trial-related decisions (e.g., associates, residents, research fellows). See also Investigator.

Subject/Trial Subject
An individual who participates in a clinical trial, either as a recipient of the investigational
product(s) or as a control.

Subject Identification Code

A unique identifier assigned by the investigator to each trial subject to protect the subject's
identity and used in lieu of the subject's name when the investigator reports adverse events
and/or other trial related data.

Trial Site
The location(s) where trial-related activities are actually conducted.

Unexpected Adverse Drug Reaction

An adverse reaction, the nature or severity of which is not consistent with the applicable
product information (e.g., Investigator's Brochure for an unapproved investigational product
or package insert/summary of product characteristics for an approved product) (see the ICH
Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited
Reporting).

Vulnerable Subjects
Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the
expectation, whether justified or not, of benefits associated with participation, or of a
retaliatory response from senior members of a hierarchy in case of refusal to participate.
Examples are members of a group with a hierarchical structure, such as medical, pharmacy,
dental, and nursing students, subordinate hospital and laboratory personnel, employees of
the pharmaceutical industry, members of the armed forces, and persons kept in detention.
Other vulnerable subjects include patients with incurable diseases, persons in nursing
homes, unemployed or impoverished persons, patients in emergency situations, ethnic
minority groups, homeless persons, nomads, refugees, minors, and those incapable of
giving consent.

Well-being (of the trial subjects)

The physical and mental integrity of the subjects participating in a clinical trial.

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RELATED SOPs AND OTHER DOCUMENTS

ICH GCP
Indian GCP
Schedule Y of Drug & Cosmetic Act 1940

PROCEDURES

1. Role & Responsibilities

Step Action
Responsibility and accountability for clinical trials will be allocated among members
1.1
of the Dr. ABC XYZ site team. This includes the administrative accountability as well
as general responsibilities of the site team and of individual team members for
fulfilling regulatory and clinical requirements.
Responsibilities of the Investigator at Dr. ABC XYZ site:
1.2
Investigator will conduct the trial in compliance with the protocol, ICH GCP &
applicable regulatory requirements.
The responsibilities of Investigator will include but not limited to:

1. The safety and welfare of participants in the trial.

2. Reading and understanding all the information in the investigator’s brochure,
the informed consent, and the protocol
3. Informing all participants, including participants used as controls, that the
investigational agents are being used for investigational purposes and
following all requirements relating to obtaining informed consent.
4. Preparing and submitting protocol documents for initial SITE EC review and
approval.
5. Conducting study activities only after SITE EC approval and in accordance with
the approved protocol, and assuring that SITE EC requirements are met.
6. Reporting adverse events to the Sponsor within agreed timelines.
7. Implementing modifications in approved research only after consultation with
sponsor followed by review and approval of the modification by the SITE EC,
except where necessary to eliminate apparent immediate hazards to
participants.
8. Appropriate control, inventory, distribution, storage, record keeping and
destruction or return of all clinical supplies including the Investigational

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Product
9. Prompt reporting of all the Serious Adverse Events to site EC.
10. Providing progress reports to the Site EC as per site EC SOP.
12. Assuring the disclosure of financial interest and arrangements to the sponsor
and the Site EC, and if required by the site EC, to participants, by any member
of the research team that may present a conflict with the interests of participants
in the study.
13. While retaining knowledge of and overall authority for the conduct of all research
studies, supervise members of the research team qualified by appropriate
education and experience to accept responsibility for study-related activities not
directly performed by the PI. Assuring that delegation of responsibilities is
appropriate and is documented and that individuals recruited as members of the
research team are appropriately licensed and trained.
14. Maintaining adequate and accurate records and making records available for
inspection to external and internal monitors, Auditors & Inspectors.
15. The PI may delegate responsibility to individual members of the research team;
however, the PI cannot delegate accountability for the ethical conduct of the
study. The PI must sign the form that delegates responsibilities to each member
of the research team. Each individual’s name must be initialed and dated. The
form must be updated, initialed and dated, each time there is a personnel
change.
Responsibilities of the Clinical Research Coordinator :
1.3
The responsibilities will be delegated to the position with the level of qualification,
training and experience appropriate to the task and in accordance with the
requirements of the trial:
1. Developing organizational aids and checklists to facilitate patient recruitment
and the collection of complete and accurate study data.
2. Maintaining the regulatory and study files for each research project.
3. Communicating with the SITE EC as appropriate.
4. Assuring proper handling of the investigational product.
5. Reporting adverse events to the SITE EC and sponsor, as appropriate.
6. Meeting with sponsor representatives to discuss planned and ongoing studies.
7. Overseeing study closure and reporting of results.
8. Participating in quality assurance activities of the sponsor & regulatory
inspections.
9. Supervising other clinical research personnel, as appropriate.
10. Participating as appropriate in the training of individuals recruited as members
of the research team.
11. Managing the business aspects of studies, including developing and negotiating
study budgets and facilitating the contract review process to assure that
provisions on publication, intellectual property, indemnification, records
retention, and data ownership are appropriately negotiated with the sponsor.
12. Design appropriate recruitment strategies and track study enrollment.

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13. Accurate and timely data entry & corrections.

14 Proper handling & processing of collected samples.

Further to above listed responsibilities medically qualified personnel will also be

responsible for the following activities.
1. All procedures requiring medical expertise.
2. Screening and enrolling subjects in studies and managing their participation
according to ethical, regulatory, and protocol-specific requirements.
3. Obtaining informed consent from trial subjects before performing any study
related procedures. Performing all the study related procedures as per the
protocol.

2. Distributing, Storing & Inventory of Investigational Drugs

Step Action
Principal Investigator- The Principal Investigator is responsible and accountable for
2.1
the distribution, storage, and inventory of the investigational drug involved in the
approved clinical study. The PI may delegate responsibility for the investigational
drug to another qualified researcher involved in the study, but may not delegate
accountability.
Upon receipt of the study drug, the shipment will be inventoried, verifying that the
2.2
receipt date, lot number, drug type, batch number and quantity on the packing slips is
the same as what was actually received;
Promptly bring any discrepancies to the attention of the Sponsor/supplier of the drug.
2.3
Retain a copy of the shipping inventory, packing slips and document inventory in the
2.4
study files;
The drug will be stored in a secure environment according to requirements listed in
2.5
the protocol or the investigator’s brochure.
The temperature of the storage area will be recorded daily, or an alarm system
2.6
maintained so research personnel will be notified if the temperature exceeds the
parameters specified for the agent. Access to the storage area will be limited to
essential research personnel.
The expiration date of the drug will be noted, and the drug will be returned, disposed
2.7
of, or destroyed in accordance with the approved protocol when the drug expires.
The site team member designated by the PI to distribute the drug to the participant
2.8
must ensure that the participant understands when and how to take the medication.
When the protocol requires the participant to record the day, times, and methods of
taking the study drug, the site team member must make sure the participant
understands how to fulfill the responsibility.
Each time the study drug is distributed to a participant at the study site, it will be
2.9
appropriately recorded. Documentation will include at least the following:
• Name of individual distributing the agent,
• Participant’s study ID and/or initials
• Amount distributed (and lot number, if appropriate),
• Date of distribution (and time, if appropriate)

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Drug accountability documentation will be completed on arrival of supplies, each time

2.10
drugs are distributed, and when drugs are returned to the sponsor or destroyed.
Compliance by the participant with the procedures described in the protocol will be
2.11
verified. Discrepancies between amounts of the drug or agent used by participants
and amounts returned and the reasons underlying any discrepancies will be
documented. If the participant has not taken the drug or agent as required by the
protocol, the PI should determine whether the participant will remain in the study or
be withdrawn.
When all participants have completed the study medication, the records will be
2.12
checked for accuracy and will be signed and dated.
During the course of the study, partial doses, used containers and tubing should be
2.13
disposed of in the manner described in the protocol, and, if they are biohazards, in
accordance with the institution’s biohazard policies.
At the conclusion of the study, the study drug should be inventoried and prepared to
2.14
be returned to the sponsor or to be destroyed in accordance with the requirements of
the sponsor or the manufacturer or the state board of pharmacy. All documentation
regarding receipt, storage, dispensing, and return of used containers must be
complete and accurate.
A copy of all accountability documents will be maintained in the regulatory files.
2.15

3. Recruitment of study subjects

Step Action
Recruitment strategies :
3.1
Participants will be recruited from a variety of sources including clinician referrals,
internet postings, newspaper advertisements, television/radio advertisements, from
support groups, health fairs, or from local hospitals and clinics. Clinicians will be
notified about research studies by letter or by word of mouth.
Recruitment Materials :
3.2
Materials directed to patients or the general public with the intent of recruiting them to
participate in clinical research must be submitted to the SITE EC for review and
approval. These include announcements, advertisements, flyers, phone scripts for
screening, oral scripts for consenting participants, newspaper ads, videos, radio and
television announcements, bulletin board tear-offs, Internet postings, and posters.
Enrolment Procedures
3.3
Recruitment rates will be regularly evaluated during the recruitment period, with
reassessment of the strategy when recruitment targets are not being met. When there
is competitive enrolment, recruitment must be continually reassessed to manage
screening of participants.
The Clinical Research Coordinator/Nurse will keep records of recruitment and will
3.4
inform the Dr. ABC XYZ and the monitor of progress in recruiting patients. Every
person who is considered a potential candidate for the study should be entered in the
Screening and Enrolment Log (based on study inclusion and exclusion criteria). Note
whether individuals have enrolled in the study and, if not, document the reason.
At the screening visit, the potential participant must give informed consent prior to any
3.5
screening procedures. Signed informed consent forms from subjects who terminated
their participation in the study during the screening process will be retained.

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After screening and/or randomization, the participant’s code/ID number will be entered
3.6
in the Screening and Enrolment Log. The Enrolment Log can serve as the coded
subject list, which must be archived at the end of the study. If there is no Screening
and Enrolment Log included in the study, a master log must be kept of all subjects
randomized in the trial, with subject name, address, year of birth, and treatment
allocation or treatment package number.

4. Informed Consent

Step Action

4.1
Obtaining Informed Consent
A completed Informed Consent Document will be obtained from every participant who
takes part in a study prior to performing any study-related activities, including
screening laboratories, vital signs, or questionnaires. On occasion, a separate
screening consent, approved by the SITE EC, may be used to document consent for
screening procedures only.
When a potential protocol candidate will be identified, the investigator or research
coordinator discusses the study in detail with the potential participant. An explanation
of the study, its risks and benefits, and what would be required of the subject will be
discussed. The subject will be given a copy of the informed consent document to read
in a quiet environment without distraction. The subject will be encouraged to take the
consent form home so that he or she may discuss it with family members. All
questions and concerns will be addressed throughout this process by the consenter
and/or PI.
If a person decides to participate, he/she will be asked to sign the informed consent
document.
Only after all questions and concerns have been addressed and the consenter is
satisfied that there is a clear understanding of the trial.
The informed consent document will be signed and dated by the participant or legal
representative along with the coordinator or investigator obtaining consent.
The original signed informed consent will be kept in the patient’s research chart (i.e.,
source documents) or in the patient’s medical record.
The participant will be given a copy of the signed informed consent document.
Documentation of the Informed Consent process will be entered in the subject’s
source documents (see Documentation Section below).
4.2
Revised Informed Consent Forms & Re-consenting

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If, during the course of the trial, the protocol has been modified in such a way that
changes are made to the Informed Consent, participants who have already given their
informed consent may be required by the SITE EC to be re-consented using the
updated form with the changes bolded. All participants currently enrolled in the study
must sign the bolded copy of the updated informed consent form to acknowledge the
changes. The participant may be re-consented at the next patient contact unless
otherwise stated by the SITE EC or study sponsor.
For potential participants who are not yet enrolled in the study, the revised Informed
Consent replaces all previous versions for the Informed Consent and is used in its
clean format. Informed Consent is obtained as described above.
4.3
Obtaining Informed consent from participant who can not read
If an investigator wishes to include a subject who is illiterate or cannot read, the
informed consent document will be read to the subject in the presence of an impartial
witness. Whenever possible, accommodations should be made to permit subjects to
read the
consent form if possible; e.g., large type for individuals with visual impairments, rather
than relying on verbal consent routinely.
The information presented to the subject must include all of the required elements of
consent and should be at least as extensive as found in the written consent form.
An impartial witness will observe and/or take part in the consent process and then sign
the consent form.
The person who is illiterate will also sign her/his mark on the signature line. When a
study is expected to include illiterate subjects, the investigator will describe during
initial review how the consent process is to be carried out and will submit a “short
form” for approval.
4.4
Obtaining consent from children
Where minors (those who are less than 18 years of age) are involved in research,
consent of one or both parents must be obtained, as required by the site EC approved
protocol.
The SITE EC may require the assent of the child. The SITE EC approved protocol will
specify whether assent is required, and when it is required, whether assent may be
verbal or must be written and signed the minor. If assent is required, the child should
be given an explanation of the proposed research procedures in a language that is
appropriate to the child's age, experience, maturity, and condition. This explanation
should include a discussion of any discomforts and inconveniences the child may
experience if he or she agrees to participate.
If the parents consent but the child does not wish to participate, then researcher must
respect the decision & should not take the child in the study.
The SITE EC may require additional protections when minors participate in research,
such as requiring that an independent third party or an advocate of the child be
present during the informed consent process.
Individuals who are “mature minors” or “emancipated minors” under the law of the
state may be able to give informed consent. If a participant is a mature minor or
emancipated minor, the researcher should contact the SITE EC before allowing the
minor to give informed consent for participating in the study.
4.5
Documentation of Informed consent process
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The PI/ medical study coordinator will maintain documentation of the decision to
delegate the responsibility for informed consent, including the qualifications of the
individual(s) selected. This will be done via a Delegation of Duties Form which is filed
in the regulatory files. This documentation shall be made available for
auditing/monitoring.
The original SITE EC approval letter and the stamped copies of the consent form will
be maintained in the regulatory file and copies forwarded to the sponsor. (See
Regulatory Preparation Section of this Manual)
The site team member obtaining informed consent will note in the source documents
the following information pertinent to The Informed Consent Process:
1. Name and title of person who explained the study
2. Name and title of person who obtained Informed Consent (if different than
above)
3. The actual date and clock time Informed Consent was obtained
4. Individual(s) present when Informed Consent was obtained
5. Name of staff, if any, who witnessed Informed Consent
6. Name of individual who signed the Informed Consent document

5. Adverse Event Reporting

Step Action
The participant will be assessed at each visit, or study assessment, for AEs that
5.1
may have occurred since the previous visit or assessment, insuring that the following
are appropriately investigated:
Spontaneous reports of adverse events by subjects
• Observations of adverse events by clinical research staff
• Reports by family members or medical care providers
• events documented in medical records or progress notes that may be AEs
• Reports of the death of a participant during the protocol-defined follow-up
period, whether considered treatment-related or not
A toxicity grade will be assigned using the grading scale described in the protocol (if
5.2
present).
All appropriate resources will be directed toward insuring the participant’s safety and
5.3
well-being.

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If necessary for the immediate medical care of the participant, the Principal
5.4
Investigator may elect to break the drug blind after consultation with the sponsor.
Therapeutic intervention measures will be taken as outlined in the protocol. The
subject should have clinical assessments (frequency to be determined by the primary
investigator unless dictated by protocol) until the AE has stabilized or resolved.
If the adverse event is serious and unexpected, the sponsor should be informed as
soon as possible after the occurrence of the event becomes known to study staff and
when the participant has stabilized (whether the AE is considered drug-related or
not) so that the sponsor can fulfil its reporting obligations to the FDA. The sponsor
should be updated as information on the AE becomes available. If applicable, the
form provided by the sponsor should be completed. As much of the following
information as possible should be provided:
• Protocol name and number
• Possible test articles: investigational product, comparator, or placebo
• Lot number and expiration date
• Study subject number/identification
• Demographic data
• Nature of the event
• Severity of the event (may be clarified in the protocol)
• Probable relationship of the AE to the investigational product
• Date (and time) of AE onset and resolution, if available
• Dose, frequency, and route of administration of the investigational product
• Start and stop dates of test article administration
• Concomitant medications and therapies
• Clinical assessment of the subject at this time
• Results of any laboratory and/or diagnostic procedures, treatments, autopsy
findings
• Follow-up plan
• Outcome
If the AE results in the subject’s death an autopsy report or death certificate will be
5.5
obtained, if required by the protocol.
Source documentation must be completed, as appropriate. The appropriate case
5.6
report form must be completed for collection of adverse event information, and copies
of all reports should be maintained in the participant’s file and the regulatory files
All SAEs should be reported to the SITE EC as per the Site EC SOP.
5.7
The IND Safety Report should be submitted to the SITE EC within ten (10) days of
5.8
receipt of the report from the sponsor or within 24 hours of the onset of the event or
the site’s having been made aware of the event.
5.9
If further action is required by the SITE EC, the sponsor should be informed.
A summary of all adverse events (both serious and non-serious) will be reported to the
5.10
SITE EC as part of continuing review.

6 Source Documentation

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Step Action
6.1 The SITE EC approved protocol describes the information to be obtained from each
participant during screening and study visits. This information will be obtained by a
variety of means including interviewing, assessment procedures and performance of
study-specific diagnostic and laboratory tests. These various processes/procedures
must be performed according to Professional Standards of Practice, applicable
regulatory requirements, and GCP (Good Clinical Practice).
6.2 Original documentation, containing the subject’s health information and medical test
results, must be retained in the subject’s medical/study record. This information may
include the clinical medical report, laboratory results, laboratory notes, copies of
hospital charts, primary physician or other related consultations, communication
between study team, subject diaries, questionnaires, check lists, photographs,
negatives, drug records, X-rays, EKGs and electronic data. Documentation should
also note if a procedure was not performed and should be accompanied by an
appropriate explanation e.g. subject refused, subject had to leave before test could be
performed.
6.3 At the start of the study, the collection of source documentation begins once each
participant has signed the approved informed consent form. This file will be updated at
each subsequent visit. Documentation, outlining any issues associated with a specific
participant’s involvement in the research study, should be updated as necessary at
each subsequent study visit with any new medical conditions or with any past medical
history that becomes known to the research team.
6.4 The original study documentation must be completed, signed and dated by the
researcher who obtained the data.
6.5 Source documentation will be completed and filed at the end of study visit. All source
documentation must be in compliance with sponsor/CRO specified recommendations.
6.6 Case Report Forms and source data are maintained separately, but source documents
should accompany the case report form for sponsor verification.

7 Essential Documents

Step Action
7.1 A regulatory file labelled with sponsor name, investigator name, protocol number and
title will be prepared for each clinical trial prior to enrolling subjects or collecting any
data.
7.2 The regulatory file will contain the following documents, as they apply to the study.
Sponsor should be consulted for the same;
• FDA Form 1572 ) listing the PI and sub-investigators and all revisions
• Financial Disclosure Forms/ SITE EC Conflict of Interest Forms
• CVs for Investigators, and all sub Investigators or other key personnel, signed
and dated. CV’s should be updated at least every 2 years, or more often if the
Sponsor requires
• Current licenses of all key study personnel
• The current Protocol signed and dated by the PI

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• Investigator’s Brochure (Investigators at all sites must have a copy) and signed
acknowledgement that the PI and sub investigators have read it.
• all SITE EC approvals
• Informed Consent forms
• Documentation of protocol deviations/violations whether SITE EC approved or
not,
• Correspondence to and from the SITE EC,
• Amendments to the Protocol,
• Progress reports submitted to the SITE EC
• Final study report (study status reports)
• SITE EC approved recruitment materials
• Form delegating responsibilities among the members of the research team,
initialed and dated by the PI for each person on the form
• Site Signature Log
• Subject Identification Log
• Site Monitoring Visit Log
• Laboratory Reference Ranges
• Laboratory Certifications
• Drug Inventory Log and Drug Labels
• Drug Return/Destruction Log
• Serious Adverse Event (SAE) Reports
• IND Safety Reports, signed and dated, and a copy of the transmittal memo to
the SITE EC and any SITE EC acknowledgement.
• Screening Randomization Log Phone Logs and Correspondence, documents/
submissions/correspondence sent and received during the study to SITE EC,
to the sponsor, and to regulatory, licensing, and accrediting agencies, including
copies of SAE notifications, faxes, emails, newsletters, meeting notes, memos
to file
7.3 The regulatory file will be maintained and updated as necessary, adding
appropriate documents as they are generated or received. The regulatory files
will be updated to reflect the following:
• Changes in Study Personnel
• Changes in Study Personnel Responsibilities
• Changes in the Financial Arrangements of Study Personnel
• Renewal of SITE EC Approvals
• Renewal of Investigator and sub Investigator CVs, Lab
• Certifications and other required licenses and certifications
• All Amendments to the protocol, Investigator’s Brochure, Informed Consent
and other key documents.

Appendix Listing

None

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Title: Standard operating procedure of site activities

SOP No.: GEN-01 Version No.: 01 Effective Date: dd-mmm-yyyy

REVISION HISTORY

SOP Page (s) Description of change(s) Superseded

Revision # Document
New SOP N/A

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