CRA study guide pt !

INDA Definition

Application filed with the FDA after completion of pre-clinical and prior to human testing.

Sample Size - Phase I

20-80

Every Clinical Investigation begins with the development of

A Protocol

What is a Protocol

A document describing how the Clinical Trial will be conducted and ensures the safety of the trial subjects, and integrity of the data collected.

What are source documents?

A source document is a document in which data is collected for a clinical trial is first recorded

What is the Pre-Clinical phase?

A study to test a drug, procedure, or another medical treatment in animals

What is a Trip Report?

A trip report is an annotated report which details the visit conducted by the CRA It is comprised of several questions regarding the visit

Design: Double - Blind

Double - Blind is where neither participant nor experiements know who is receiving drug. Only Sponsor knows DB is used to prevent bias due to demand characteristics or the placebo effect.

Where is the Visitor Confirmation Letter located?

In the ISF with P.I.'s signature of initials, and date confirming he/she reviewed --be sure to send confirmation letter before every visit--

Why should site file a NTF

Instruct site to notify sponsor and keep you the CRA in copy

Acronym: INDA

Investigational New Drug Application

Because No drug is completely safe, what is important?

It is important to estimate the risk associated with exposure to the chemical under specified conditions by performing appropriate tests.

Popoulation of Phase IV

Mixed

NDA: Definition

NDA is an application filed with the FDA for sale and marketing of the drug product

The most performed Clinical Trials evaluate ---

New drugs Medical devices (drug-eluting stent, insulin pen) Biologics (blood, vaccines, tissues) Psychological therapies or other interventions

When is the Confirmation Letter sent

Once CRA schedules an onsite monitoring visit, depending on the time outlined on the monitoring plan

What does "Randomize" mean

One Group is assigned to an experimental group and one group is assigned to a controlled group (You don't know what group you will get assigned to)

When does the visit occur

Pre-Qualification (PQV) occurs once a site has been identified by the CRO or sponsor

Types of Visits

Pre-Qualification Visit (PQV) Site-Initiation Visit (SIV) Routine Monitoring Visit (RMV) Close Out Visit (CIV)

Usually, Confirmation Letters are addressed to_________, and sent to ______, to be ________

Principal Investigator, Study Coordinator, filed in the Investigator Site File (ISF)

When does this visit occur

SIV (Site Initiation Visit) occurs once the site has been selected to participate in the study and the site has provided all approvals and regulatory documents have been submitted

Design: Single - Blind

Single - Blind is used with a placebo. Subject is unaware if they're receiving study drug or placebo. Study Team knows if subject has drug or placebo.

What are the steps if a Temperature Exclusion occurs

Site should fild NTF to indicate what occured, i.e. why did the temperature excursion occur what was done what can be done to prevent further temperature excursions

What effects can happen from bias drug groups

Skews the data

SDV vs SDR:

Source Data Review - When data in the subjects chart is reviewed Source Data Verify - When the data that is being reviewed is cross referenced to what the site has entered into the EDC

When do you used the Subject Logs? (drug accountability)

When SDV'ing the drug eCRF pages. You will be confirming that whatever amount is listed in the EDC is recorded on the subject drug dispensing log

Most TR questions require this type of response

Yes or No response

What is a Temperature Exlusion

a Spike or Drop in the temperature of storage location

What does an INDA contain:

pre Clinical data: Animal Pharmacology Toxicology Studies

Randomization prevents:

preferential drug or placebo administering (I cant assign my friends to experimental group, because I want them to get the drug. Can not assign by sex, race)

INDA: Unless the FDA--

specifically objects, the IND is automatically allowed after 30 days and clinical trials can begin

What does the Confirmation Letter outline?

the Confirmation Letter outlines an agenda or the topics you plan to address during visit

The Protocol Document describes what aspects of the Clinical Trial?

the objects the design the methodology statistical considerations organizations of a Clinical Trial

What if a temperature exclusion is noted

the site should be instructed to quarantine the drug (remove the affected drug until further instruction is received)

How many visits per study

Visits occurs once per study site

Each Study's Trip Report comes with

annotated guidelines which provide instructions on how to answer the questions within the TR

Some Confirmation Letters might also list --

lists outstanding action items from the previous visit, that requires follow-up or resolution during your visit

No chemical can be certified as completely---

"Safe". Every chemical is toxic at some dosage.

What to collect for Drug Accountability

1. A copy of the Drug Accountability inventory, subject, and destruction logs are collected 2. A copy of the month's temperature logs are collected 3. Drug shipping packing list

What does Drug Accountability require the Monitor to confirm?

1. Drug is being stored within the specified temperature parameters 2. The correct dosage was given to the subject 3. The drug has not expired 4. The used drug has been destroyed or shipped back to the sponsor

Source Data Verification: Purpose of SDV

1. Is a process to evaluate the conformity of the date presented in CRF (Edc system) 2. to ensure data collected are reliable and allow reconstruction and evaluation of the study

What info is reviewed through an NDA

1. Is drug safe and effective in it's proposed use as directed, and do benefits outweigh the risks? 2. Is drug's proposed labeling (package insert) appropriate, and what should it contain? 3. Are the methods used in manufacturing (GMP) the drug and the controls used to maintain the drug's quality adequate to preserve the drug's identity, strength, and purity?

Different types of Source Documents?

1. Original Paper Documents 2. EMR record 3. or Certified copies of the EMR

Purpose of Monitoring

1. to educate study staff on drug handling protocol procedures: GCP, safety reporting, and ethical issues 2. Maintain temporal sequence of event (to follow the study of assessments) also termed: Contemporaneous 3. Adherence to protocol, GCP, SOP, Regulatory and Data Cleanliness 4. To ensure consistency 5. To prevent fraud

Sample Size - Phase lll

100-1000

Sample Size - Phase ll

100-200

Sample Size - Phase IV

1000 +

Design: Open

Both the investigators and the subjects know what is being given. There is no placebo

SD: This data is later entered in _____

Case Report Form

Purpose of Clinical Trials?

Clinical Trials are conducted on human volunteers to allow safety and efficacy data to be collected for health interventions.

What does the Confirmation Letter confirm

Confirms the visit day and time previously agreed on

Perform Drug Accountability

Drug Accountability is completed by 1. taking an inventory of the Drug Supply (How much drug is on hand-What is the expiration date of drug) 2. collect lot/batch of each vial or bottle on site and total up your count. You will need this info for your Trip Report

What is Drug Accountability

Drug accountability is record keeping associated with storage, inventory, dispensation and destruction of the investigation Product (IP) used in Clinical Trials

Number of Clinical Trial Phases?

Four (4)

Number of Visits

Four (4)

Acronym: GMP

Good Manufacturing Practice

Population of Phase l

Healthy Volunteers

In Drug Accountability: Each site is provided with what?

Sponsor specific drug logs to log the amount of drug received for the site and subjects logs to log the amount of drug being dispensed or administered to the subject, and destruction logs to log the amount of drug used/dispensed

Population of Phase ll

Target Disease Patients

Population of Phase lll

Target Disease Patients

Who/What does most "randomizatoin"

The Computers

When is an NDA submitted

The NDA is submitted after completion of Phase l, ll, and lll studies of Clinical Trials

What is the purpose of a CRA

The Purpose of a CRA is to monitor Clinical Trials.

Purpose of Routine Monitoring Visit

The RMV is to ensure that the site is adhering to all study procedures

What is the aim of the Pre-Clinical phase?

The aim is to collect data in support of the safety of the new treatment

When does this visit occur

The first RMV is typically conduted two weeks after the first subject has been enrolled / randomized. Guidelines for scheduling monitoring visits shall be determined according to stage of of development, complexity of study, rate of subject accrual and other factors

Who are CRAs?

They are health professionals who perform many activities related to medical research, particularly Clinical Trials.

# of Principles in GCP

Thirteen (13)

Purpose of a Pre-Qualification Visit (PQV)

This visit is to determine whether the site meets the standard qualification to conduct the study

How many SIV visits per study

This visit occurs ONE (1) time per site per study

How many RMV per study

This visit occurs multiple times throughout the study at each site

How many visits per study?

This visit only occurs 1 time per site per study

Purpose of Site Initiation Visit (SIV) : -In Short:

To ensure PI and all research team assisting in the conduct of clinical research are informed about their obligations and responsibilities as they pertain to GCP, Investigational plan, applicable regulations, guidances and institutional policies. - The SIV prepares the site to conduct the research study

Acronym: TR

Trip Report

When does Close Out Visit occur

Visit is conducted at Termination of study, unless enrollment closes for the study and the site never enrolled a subject

When you get onsite, one of the things you might want to look for is?

Visitor Confirmation Letter that you previously sent

Purpose of Close Out Visit -- In short

to ensure that things are neat and tidy at the study site, and that the documentation is well organized and will remain in-tact and accessible in the future as needed, for regulatory reasons -To confirm sites obligations to the sponsor have been met, and any post study obligations are understood as well as followed through on.

Oftentimes, the Clinical Trial Leader or Project Manager will prepare-

will prepare a Template that you can use to draft your Confirmation Letter