Docstoc

IP_Randomisation_CRF entry

Document Sample
IP_Randomisation_CRF entry Powered By Docstoc
					1

IP,Randomisation,CRF entry Shiva, Ram,Anil,Arsheya,

The learning objectives for Module 4 are that: As an investigator or member of the research team, you
will be able to do the following, based on ICH guidelines: Be familiar with accountability and
management of investigational product (IP) - including storage, dispensing, and handling all IP,
maintaining appropriate inventory records, and following proper unblinding procedures based on the
trial protocol, Investigator's in ICH Sections 4.6, 4.7, and 7, and for those conducting a trial under a US
IND, FDA regulations are found in Title 21 CFR Part 312. Other local regulatory guidelines may apply
based on the location of the trial. ICH defines an investigational product as a pharmaceutical form of an
active ingredient or placebo being tested or used as a reference in a clinical trial. In clinical trials, the
investigational medication, placebos, and/or active comparators, are considered investigational
products. Therefore, investigational product requirements apply to all three. ICH calls for the
investigator to be thoroughly familiar with the appropriate use of the investigational product. Resources
available to the investigator include the protocol, the current Investigator's Brochure, and other
information that may be provided by the sponsor. In addition, there is product information or a package
insert for marketed drug products. The Investigator's Brochure (also referred to as the IB) is the most
complete source of information about the investigational product. It provides a compilation of clinical
and non-clinical data on the product, relevant to the study of the investigational product in human
subjects. The primary purpose of the Investigator's Brochure is to provide the investigator with a clear
understanding of: Possible risks Adverse reactions Specific tests Observations, and Precautions The
Investigator's Brochure is used for products not yet approved by appropriate regulatory authorities, and
the packet insert, or full prescribing information, is used for products that have already been approved
by appropriate regulatory authorities. The contents of the Investigator's Brochure, as specified in ICH
7.3 include: A description of investigational product - including physical, chemical and pharmaceutical
properties and formulation, The non-clinical data, such as pharmacology, pharmacokinetics and
metabolism, as well as toxicology studies, Any available clinical data on the effects in humans including
pharmacokinetics and metabolism, safety and efficacy data as well as marketing experience. And last,
there should be a summary of data and guidance for the investigator which provides the most
informative interpretation of the available data with an assessment of the implications for future trials.
In addition to the principal investigator, who needs to be familiar with the contents of the Investigator's
Brochure? Certainly subinvestigators, such as other physicians who are enrolling subjects and managing
patient care, need to be familiar with the content. Research staff, as well as nurses and pharmacists who
are caring for subjects or are responsible for dispensing or administering study medications need to be
knowledgeable about investigational product. And last, Institutional Review Boards and Independent
Ethics Committees need to review the Investigator's Brochure to assess the risk/ benefit ratio, and to
compare the risk/safety data in the Investigator's Brochure o the data that is provided in the written
informed consent form. It is critical that all individuals involved in the medical care of subjects and
responsible for protecting their safety are well informed and kept abreast of the known or observed
adverse events or risks. Responsibility for investigational product accountability at the site rests with the
principal investigator. When the principal investigator delegates responsibility for investigational
product accountability to a member of the research team, such as a pharmacist or research coordinator,
the principal investigator is to provide supervision. Maintaining adequate product inventory records
requires: Documentation of receipt, including a record of any product received damaged and unusable,
2

IP,Randomisation,CRF entry Shiva, Ram,Anil,Arsheya,

Documentation of use by subject, including use, loss, damage and return Documentation of final
disposition: return of unused supply to sponsor or alternate disposition, such as on-site destruction.
Records should include: dates, quantities, batch/serial numbers, expiration dates (if applicable), unique
code numbers assigned to investigational product and subjects, and the signature or initials of
designated staff. Drug accountability requires: Using investigational product in accordance with the
protocol, Dispensing only to eligible, consented subjects, Explaining its correct use to each subject,
including how to handle and/or store investigational product and verifying the subjects and/or
caregivers understanding of product use and handling, and Securing subject compliance Accountability
logs may include: the subject and investigational product pack identification, date dispensed, amount
dispensed, dispensed by whom with signature and/or initials, date returned, amount returned, received
by whom with signature and/or initials, and final sign off. At times there is a need to transport
investigational product from one location to another within a site, such as transfer from the main
pharmacy to a research pharmacy, or from one site to another site. In either case, sponsor approval
should be obtained prior to transfer. It is important that appropriate procedures be followed to ensure
integrity of investigational product during transport within a site or to another site. In the case of an
investigational product shortage, transfer of product from one site to another may require
investigational product re-labeling. Most sponsors will require that investigational product be sent to
them first for a quality control check prior to shipment to another site. If a subject is lost to follow-up
and is still in possession of investigational product, the following actions should be taken: The
investigator should attempt to retrieve all unused investigational product from the trial subject. The
sponsor or CRO may provide instructions as to what due diligence is required in retrieving
investigational product and supplies from non-compliant subjects. Due diligence for example might
consist of: Contacting the subject by phone and requesting that they return to the site for a safety
evaluation as well as to return the investigational product. If they cannot be reached by phone, most
sponsors or CROs request that the site send a registered (certified) letter requesting the subject return
for safety evaluation and return the investigational product. A preprinted label with return address
might be provided so that subject can ship investigational product back to the site. Typically, the
shipment of investigational product from the subject to the site is not via registered mail. Detailed
documentation of all attempts to contact the subject, as well as any successful contacts made is
important. This includes documentation of all attempted phone calls and actual phone contacts, as well
as letters sent, and acknowledgement of receipt provided by the postal company. This documentation
provides a record of due diligence. If it is not possible to contact the subject or they do not return
investigational product after all due diligence efforts have been made, the details of all missing
investigational product should be documented including details of the measures taken to obtain the
product as noted above. The storage of investigational product must comply with all sponsor
requirements and provide secure, restricted access and appropriate storage. This includes all
temperature conditions, times, procedures and instructions as specified by the sponsor and in
accordance with local regulatory requirements. For example: "a secure, limited access, locked when not
in use" area might be required, or product must be kept with the appropriate temperature controls and
a temperature log may be required to document the maintenance of required temperatures. If the trial
is conducted under a US IND, Title 21 CFR 312.69, states that if investigational product is a controlled
3

IP,Randomisation,CRF entry Shiva, Ram,Anil,Arsheya,

substance, meaning that it is on the Drug Enforcement Agency schedule because it has abuse potential
and/or street value, the investigational product must be stored in a securely locked, substantially
constructed cabinet or other enclosure with limited access, to prevent theft or diversion into illegal
channels of distribution. Investigational product labeling is not an investigator responsibility but that of
the sponsor. However, investigators need to be aware of the following information: Labels should be in
the local language for the location where the trial is being conducted. This is noted in ICH 5.13. Examples
of the information that may need to appear on the label include: Name of the sponsor or manufacturer,
Dosage information, such as form, route, quantity and frequency, Batch and / or code number, Subject
identification, Directions for use such as "take after food", A statement that the product is for clinical
trial use only, Investigator and site identification, Storage and handling instructions, Period of use,
manufacturing date, expiration date, Notation to "Keep out of reach of children", Instructions to return
unused medication and empty packaging, and Any appropriate warnings Instructions regarding
procedures for the return or destruction of unused product will be specified by the sponsor. Instructions
will include the investigational product return/destruction forms to be used, directions for shipment or
proper method of destruction of product on site (for example, incineration), return and/or destruction
of code breaks, customs information, etc. Reconciliation is generally the final process of ensuring that
number of IP containers received by the site have been returned to the sponsor or documented as
lost/discarded. Randomization procedures will be specified for each trial and provided by the sponsor
or CRO. The coding or blinding system for the trial should allow for rapid identification of the product for
an individual subject in the case of medical emergency, but must not permit undetectable breaks of the
blinding. This is the sponsor's responsibility. It is the investigator's responsibility to ensure that the code
is broken only in accordance with the protocol. Most sponsors request that they be contacted prior to
unblinding, if time permits. Every time a code is broken it must be documented promptly along with the
reason the code was broken. This includes accidental code breaks. The sponsor or CRO needs to be
notified immediately. The code must be accessible 24 hours a day, but must also be kept in a secure
place with limited access. This might be a locked cupboard, but should not be a private office with no
access when the occupant is not there. There are companies which provide telephone randomization
and code break services. So when should the investigator break the blinded code? The answer is, when
the immediate treatment of the subject depends upon the medication taken. On the other hand, when
should the blind be maintained? The answer is, when there is no difference in how you would
immediately treat the subject, regardless of the IP taken - active study drug or placebo. It is important
to be aware that if the blind is broken, the subject will no longer be evaluable and may not be able to
continue in the trial even after recovering from the event. This slide shows an example of a drug
accountability form. In this example, a box containing 10 tubes of trial cream is given to each subject at
each weekly visit. The cream is applied once per day of treatment, therefore, there are 3 extra tubes
dispensed. Subjects come to see the investigator every week and at each visit the subject must return
the used/unused tubes. Subject -1 ROP started using the trial cream R056 on Oct 1, 2006. At the visit on
October 8, 2006 the subject returned 7 used and 3 unused tubes and was issued the next box of trial
cream. The subject continues in the trial. Subject -2 SSD started using the trial cream R057 on Nov 4,
2006. At the visit on Nov 11, 2006 the subject returned 8 tubes, 4 of which were used. The subject
withdrew consent and refused to continue in the trial. The site would need to try to obtain the two
4

IP,Randomisation,CRF entry Shiva, Ram,Anil,Arsheya,

missing tubes and document all attempts. Subject -3 GRT started using the trial cream R058 on Nov 11,
2006. On Nov 18, 2006 subject was unable to attend the visit because he was hospitalized due to a
severe adverse event on Nov 16, 2006. The subject's next visit was Nov 22, 2006 and he returned 7
unused tubes, 2 used tubes, one of which was half-used, and 1 tube was damaged. The remaining
portion of this module will cover the principal investigator's responsibilities pertaining to source
documentation and case report form completion. Regulations regarding these topics are found in ICH
GCP 6.10 and for those conducting a trial under a US IND, Title 21 CFR 312.60, 62 and 68, as well as Title
21 CFR Part 11. Other local regulatory guidelines may be applicable based on the location of the trial.
Before we can talk about source documentation we need to understand what data are considered
source data. The ICH definition, found in ICH GCP 1.51, is that "source data is 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". The source data is then found
in what is considered to be the source documents. Basically, the first point of entry of any data
pertaining to the trial is considered the source document. These are the original copies or certified
copies. As noted on the slide, a number of data sources can be considered source documents. For
example, the subject's medical file, the case report form, or a subject diary. ICH 4.9 states that the
investigator is required to prepare and maintain adequate and accurate case histories. These case
histories are documented on Case Report Forms, with documents supporting the case report form
entries, such as the informed consent, and medical records (including physician progress notes, nurse's
notes, hospital records, etc). It is important to note that the case report form cannot serve as the
complete investigation record. There must be supporting records. The subject can also complete source
documents, for example a subject diary card or questionnaire. These documents will be trial specific. A
diary card can be a very important source document as it can identify adverse events, concomitant
medication or other important information. For each trial the source document for the various
parameters should be identified at the start of the trial and documented. Subject medical files are the
documents used most frequently. If the case report form is a source document, this should be specified
in the trial design section of the protocol. Information stored on a video, such as angiography, can also
be source data. Source data can also be captured electronically as seen with EKGs, lab results, use of
computerized medical records, etc. When local laboratories are used, remember that the lab book
containing raw data is the source and is auditable. Hospital records, whether paper or electronic,
containing subject data for emergency room and outpatient visits, hospitalizations, etc., are source data
and auditable. The principal investigator must become familiar with the institutions medical records
policies and system to ensure GCP compliance will be met and maintained during the trial and record
retention period by all individuals involved with study records. Source data and documents for screen
failures need to be treated in the same manner as for randomized/enrolled subjects. These records are
monitored and auditable. Remember: Adequate source documentation would be that which permits a
reader to reconstruct all events which occurred with this subject during the trial. All entries should be
signed and dated by the individual generating the information. Source data verification is theprocess of
verifying trial data by comparing case report form entries and other trial specific records to source
documents for accuracy and completeness. Any discrepancies must be explained and documented. The
monitor from the sponsor or CRO will conduct the source document verification process. Some sites
5

IP,Randomisation,CRF entry Shiva, Ram,Anil,Arsheya,

may have an internal quality control step/process where a designated individual on the staff performs
source data verification. It is important to remember that the data transcribed from source documents
to the case report forms is what the sponsor and eventually the regulatory authorities will rely on to
determine the safety and efficacy of the investigational product; therefore data needs to be complete,
accurate, legible, and valid. Upon request of the monitor, auditor, IRB/IEC or regulatory authority, the
investigator and institution should make all trial-related records available for direct access. According to
the ICH/GCP guidelines, all investigator sites must be able to provide 'direct access' to source data in
order to participate in clinical research trials. Direct access is permission to examine, analyze, verify and
reproduce records and reports that are important to the evaluation of a clinical trial. This should be
detailed in the protocol agreement, which the investigator signs, and the signed informed consent,
which the subject reviews, so that both the investigator and subject give consent before entry to the
trial. The confidentiality of records that could identify subjects or contain sponsor's proprietary
information should be protected, respecting the privacy and confidentiality rules in accordance with
applicable regulatory requirements. The investigator's responsibilities include: Maintaining up-to-date
source documents, Ensuring consistency of Case Report Forms with source documents, Correctly
following the procedure for making changes or corrections to the case report forms. Entries must be
signed and dated with no "back dating", Explaining all discrepancies, and Ensuring all documentation is
accurate, complete, legible, and reported and recorded in a timely manner. The investigator must
review all source documents. When the source data is, for example, a hematology report it should be
reviewed by the investigator or designate within a timely fashion. A comment should be written as to
the clinical significance of a result, for example, "not clinically significant", or NCS, on the source
document, and the report signed and dated. A detailed explanation must be given if any value is
clinically significant. Finally, always remember that subject safety is the most important concern. The
minimum information required in each subject's medical file includes the: Protocol number, Date of the
signed informed consent, Current and past medical history, Dates of all visits, Dispensing details for the
investigational product - what medication was dispensed to the subject, subject compliance, and what
product was returned (if applicable) etc. If they took more or less than required by the protocol, an
explanation needs to be provided. Concomitant medications taken by the subject should also be
recorded, Adverse events and serious adverse events, The primary efficacy variables, and last The date
that the subject completes the trial or withdraws from the trial should be noted. Reasons for withdrawal
should be recorded. The best practice is to remember that if auditors or inspectors do not find the
information documented they will assume that it did not happen and does not exist. Although progress
notes prepared by a sponsor are generally considered to be more complete than some other source
documents, it is not always considered to be a good "stand alone" source document. In addition to the
sponsor provided progress note, there should be test results, signed informed consent forms, drug
inventory logs, etc. The documentation should give a clear and complete picture of what events have
occurred with this subject since the last visit. Source templates of blank CRFs sometimes limit what site
staff will document. For example, data such an adverse event or a signature and date may not be
recorded because the staff "did not see a space for it". Direct access to medical records or charts is
preferred. If it is impossible to have direct access to medical charts, it is critical for the site to inform the
monitor, sponsor, or CRO of this restriction as soon as possible. Some sponsors have a policy to select
6

IP,Randomisation,CRF entry Shiva, Ram,Anil,Arsheya,

only those sites who can provide direct access to source data. For this reason, the site must let the
monitor know the policies of the medical institution at the start of the study. Case report forms may be
in either a paper or electronic format. The sponsor designs the forms to capture the data required by
the protocol. The investigator or designate is to ensure that source data is transcribed accurately and
completely from source documents to the paper CRF or the electronic CRF. The sponsor or CRO will
inform the investigator or designate of the required timelines for form completion. Typically, sponsors
expect case report forms to be completed within 24-72 hours of the subject's visit. Paper CRFs must be
legible. The monitor will spend a large portion of their visit conducting source document verification to
ensure high quality data is being captured on the case report forms. It is important for investigators and
research staff to know how to make corrections to source data and CRFs per ICH GCP. Typically, there
should be a single line through the error, with the correct data legibly printed next to the error. Care
should be taken not to obscure the original entry in order to provide an audit trail. The correction should
be initialed and dated. An explanation should be provided as indicated. Never back date an entry, or use
correction fluid. In most situations, black or blue ink should be used for documentation. Some sponsors
will specify the use of black ink. As mentioned, some sponsors are using electronic case report forms or
electronic data capture programs. These systems require an explanation to be entered when a
correction is being made to data already submitted. The system is programmed to automatically capture
the name of the individual who made the correction, date and time of correction, the original entry and
the new information. Care should be taken to avoid signature irregularities such as: Signing on behalf of
someone, even if authorized to do so, Signing a signature other than your own, Dating a signature other
than your own, or Back dating a signature Competent authorities do not look favorably on these
practices. When signature irregularities are detected, it sends up a red flag as to the potential for
scientific misconduct or fraud. There are some common errors to be aware of when completing case
report forms. The first is missing data. This may be the result of: Incomplete forms, or blank fields,
Unreported data, such as previous history, concurrent illnesses, concomitant treatments or adverse
events, Forms not received/lost, or Corrections on source documents that are not entered on CRFs The
second common source of errors is poorly completed forms. These errors occur due to: Illegible data,
symptom after the "absent" box was checked, or inconsistency within the same visit, or Evolution
between visits, showing inconsistent dates, inconsistent "stable" variations (such as adult height), or an
"unreasonable" lack of natural variability. The next slides discuss specific FDA regulations that are
applicable only for those studies conducted within the US or under a US IND. There are specific
regulations cited in FDA Title 21 CFR 11 regarding the use of electronic records and electronic
signatures. ICH 5.5.3 states the responsibilities of sponsors when the sponsor chooses to use electronic
trial data handling systems. It does not address the investigators responsibilities when they or their
institutions use computerized systems to capture clinical trial data. Compliance with Title 21 CFR Part
11 is the investigator and institution’s responsibility. They are responsible for knowing if they will be
using computerized systems to capture clinical trial data and whether those systems are compliant with
Part 11. The site is responsible for ensuring their systems are compliant with Title 21 CFR Part 11. Should
the sponsor provide an electronic data capture (eDC) system for sites to capture clinical trial data, the
sponsor is responsible for ensuring that the electronic data capture system is Part 11 compliant.
However, the site may still bear some responsibility if they do not follow the specific training provided
7

IP,Randomisation,CRF entry Shiva, Ram,Anil,Arsheya,

on the use of the sponsor-provided data system. For example, they are instructed to "not share your
password with anybody" and the site has the password taped to the side of the computer when the
monitor visits. Compliance with this regulation has been very challenging. When the FDA implemented
it, they included very demanding, specific technical requirements that the industry did not have the
software to satisfy. Virtually all of the software and systems used by sponsors, CROs or sites became
non-compliant when this regulation took effect in 1997. Companies and sites had to re-write much of
their software on a line-by-line basis, with corrections to every prior version upon which the current
software was based. The FDA Guidance published in August 2003 indicates that the FDA is reassessing
the technical aspects of the regulation, but not the security aspects of the regulation; that remains
intact and the FDA is enforcing the security aspects of the rule as they relate to the integrity and validity
of clinical trial data. The goal of regulations regarding electronic records and electronic signatures is to
provide standards for industry to follow which will provide assurance that clinical trial data obtained via
computerized means and/or submitted electronically to the FDA in an application are as valid and
trustworthy as data submitted on paper. In addition, when electronic signatures are employed, ensuring
that all authorized individuals understand that their electronic signature has the same significance under
law as their handwritten signature. Electronic records and signatures were created to facilitate faster
submissions and to reduce paper. FDA 21 CFR Part 11 applies to any electronic records or signatures that
are submitted to the FDA or that are required to be maintained for clinical trials. The regulations also
apply to any computer systems that are in place to support these data bases. If the site is using a
computer system for the collection of electronic data on case report forms, your signature will be an
electronic signature. If using one of these systems, it is important to understand the requirements for
electronic signatures and the need to certify to the FDA that your electronic signature is the equivalent
of your handwritten signature. This is a one-time certification. For additional information regarding
certification of your signature, please contact your sponsor for guidance. Electronic signatures can be
biometric or non-biometric. An example of a biometric signature is a retina scan or thumb print. An
example of a non-biometric signature is the use of unique identifiers plus secret passwords. This type of
electronic signature is more common because biometric scans are more expensive to implement.
Electronic signatures must be unique. The system must require electronic signatures at Initial signing,
Subsequent signings, and Re-authentication intervals To be in compliance with ERES or 21 CFR Part 11,
the site must know what computer systems are being used in their facility that will contain clinical trial
data submitted to the sponsor or to the FDA as part of marketing applications. The computer systems
must be in compliance with the rules and are subject to inspection by the FDA during an audit. Examples
of computerized systems that the site/institution may be using to capture clinical trial data are: lab
results, EKGs, MRIs, computerized medical records, etc.. Investigators and institutions should become
familiar with 21 CFR Part 11 and the related guidance document. In addition, the investigator and the
institution should develop a plan for assessing all of the computer systems that may be used for
collection of data for a clinical trial and then developing and implementing a plan to bring all systems in
compliance with Part 11, if necessary. The FDA has made inspectional observations about non-
compliance of computer systems with Part 11, so it is in the investigator's best interest to know the
compliance status of the computer systems that are used at his/her site. In addition, the investigator
and institution should inform the sponsor of the level of compliance with Part 11 at the clinical sites. All
8

IP,Randomisation,CRF entry Shiva, Ram,Anil,Arsheya,

instructions provided by the sponsor regarding the use of a sponsor-provided electronic data capture
system, especially regarding security, should be followed. The sponsor or CRO cannot certify to the FDA
on behalf of the investigator or institution. The letter must be hand-signed by the site and they must
submit it to the FDA. A sponsor or CRO can collect letters from sites and submit them to the FDA. The
certification is used by the FDA to establish the site's subjective intent to have electronic signatures be
valid. It is necessary because the law has always held that only handwritten signatures are legally
binding; sending a hand-signed letter to the FDA overcomes that legal hurdle. If a signature comes to
the FDA electronically from a site that has not filed an Electronic Signature Certification, it becomes a
"red flag". The FDA may have reason to be concerned about security and data integrity. In summary,
The Investigator's Brochure provides clinical & non-clinical data on investigational product relevant to
the clinical trial The investigator/institution is accountable for the storage, dispensing, handling, and
inventory reconciliation of investigational product The investigator is responsible for following the
randomization and unblinding procedures as outlined in the protocol Source data consists of all
information in the original records/certified copies regarding clinical findings, observations, and other
activities necessary for evaluation of the trial Source data verification is the process of checking the data
consistency between the case report forms and the source documents and requires access to source
documents by the monitor, auditor, IRB/IEC and regulatory authorities Additional key points discussed in
this module include: Maintenance of accurate, complete case report forms is the responsibility of the
investigator In addition, if compliance with FDA regulations is required for the clinical trial: The
investigator/institution should be familiar with the FDA 21 CFR Part 11 and the FDA Guidance document
which outline regulations for electronic records and electronic signatures The investigator/institution
should assess all computer systems in use at the site and develop a plan to bring systems into
compliance with 21 CFR Part 11, and last The investigator must submit certification of electronic
signature to the FDA Thank you for your participation in Module 4 of the "Introduction to the Clinical
Drug Development Process: ICH Good Clinical Practice for Clinical Trial Sites. You will now be directed
back to the presentation page of the website. In order to receive your certificate of completion, please
click on the "Take Assessment" link under the module that you have just completed. That link will take
you to the final assessment and evaluation form for the module. You must complete both the
assessment questions and the evaluation to receive your certificate. Successful completion requires that
75% of the questions be answered correctly. The appropriate certificate - CME, nursing CE, or Quintiles
Certificate of completion will automatically be generated based on your registration. Your feedback is
important to us. Thank you for taking the time to complete the assessment and evaluation process.

Question 1: What information is provided in the Investigator's Brochure?
Rationale: The correct answer is "Current clinical and non-clinical data on the investigational
product"
Your Answer: Current clinical and non-clinical data on the investigational product
Question 2: Who is responsible for storage, handling and reconciliation of investigational
product inventory?
Rationale: The correct answer is "Investigator"
Your Answer: Investigator
9

IP,Randomisation,CRF entry Shiva, Ram,Anil,Arsheya,

Question 3: Who is responsible for labeling of investigational product?
Rationale: The correct answer is "Sponsor"
Your Answer: Sponsor
Question 4: True or False: The blinding code should always be broken when a subject is seen in
the emergency department to ensure complete evaluation of current medications.
Rationale: The correct answer is "False"
Correct Answer: False
Your Answer: True
Question 5: Which of the following statements is NOT true regarding source data?
Rationale: The correct answer is "Is found only in the case report forms"
Your Answer: Is found only in the case report forms
Question 6: True or False: Source data verification is the process of checking for consistency of
subject treatment with the protocol.
Rationale: The correct answer is "False"
Your Answer: False
Question 7: Which of the following is NOT a responsibility of the investigator regarding source
documents?
Rationale: The correct answer is "Conducting the source data verification process"
Your Answer: Conducting the source data verification process
Question 8: Which of the following statements is true regarding correction of data in case report
forms?
Rationale: The correct answer is "A single line is placed through the error, initialed and correct
data is printed next to the error without obscuring the original entry"
Your Answer: A single line is placed through the error, initialed and correct data is printed next
to the error without obscuring the original entry
Question 9: Which of the following is NOT true regarding case report forms?
Rationale: The correct answer is "They are used in place of the medical record for patients on
clinical trials"
Your Answer: They are used in place of the medical record for patients on clinical trials
Question 10: What is the responsibility of the investigator, participating on a US IND trial,
when using electronic records and electronic signatures?
Rationale: The correct answer is "Ensure compliance with FDA regulations and submit
electronic signature certification to the FDA"
Correct Answer: Ensure compliance with FDA regulations and submit electronic signature
certification to the FDA
Your Answer: Ensure compliance with FDA regulations and submit electronic signature
certification to the Sponsor

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:980
posted:4/26/2010
language:English
pages:9