Introduction

A survey is a method of gathering information from a sample of people, traditionally

with the intention of generalising the results to a larger population. Surveys provide a
critical source of data and insights for nearly everyone engaged in the information
economy, from businesses and the media to government and academics. There are
four modes of survey data collection that are commonly used:

1. Face-to-face surveys
2. Telephone surveys
3. Self-administered paper and pencil surveys
4. Self-administered computer surveys (typically online)

Benefits of surveys:

· (Uncover the answers) A non-intimidating survey environment is one that best

suits the privacy needs of the survey respondent. Respondents are more likely to
provide open and honest feedback in a more private survey method. Methods such
as online surveys, paper surveys, or mobile surveys are more private and less
intimidating than face-to-face survey interviews or telephone surveys.

· (Evoke discussion) Survey respondents get an opportunity to discuss important

key topics. This allows deeper understanding into the survey, and can incite topics
related to your survey within a broader perspective.

· (Base decisions on objective information) Conducting surveys is an unbiased

approach to decision-making. You can collect unbiased survey data and develop
sensible decisions based on analysed results. By analysing results, you can
immediately address topics of importance, rather than waste time and valuable
resources on areas of little or no concern.

· (Compare results) Surveys results provide a snapshot of the attitudes and

behaviours – including thoughts, opinions, and comments – about your target
survey population. This valuable feedback is your baseline to measure and
establish a benchmark from which to compare results over time.

Surveys are used to increase knowledge in fields such as social research and
demography. Survey research is often used to assess thoughts, opinions, and feelings.
Surveys can be specific and limited, or they can have more global, widespread goals.
Surveys results provide a snapshot of the attitudes and behaviours – including
thoughts, opinions, and comments – about your target survey population. This
valuable feedback is your baseline to measure and establish a benchmark from which
to compare results over time.
In this PFE course we are doing a minor project where we conduct surveys to find the
“Good Practices(GxP) followed by professionals in biotechnology field”. From this
survey we will be able to analyse, how often professionals such as researchers,
research fellows, professors, biotechnologists, etc. are encountered with ethical
dilemmas and how they were able to deal with it, what ethics they follow in their
workplace and their opinion in improving the ethical system in biotechnology field
workplaces.

Theory:

GxP is a set of regulations and quality guidelines formulated to ensure the safety
of life sciences products while maintaining the quality of processes throughout every
stage of manufacturing, control, storage, and distribution. The GxP standards were
established by the Food and Drug Administration for a range of compliance related
activities and are recognized as:

G: Stands for ‘good’

x: Variable

P: Stands for ‘practices’

The variable “x” depends on the application of the standards. The value of x can be M
for “Manufacturing”, C for “Clinical”, L for “Laboratory”, S for “Storage”, D for
“Distribution”, R for “Review”, etc. The purpose of the guidelines is to ensure that the
regulated organizations comply with the standard processes of various functions. The
guidelines mainly focus on the following areas:

● Traceability – ensuring that the development history of the product can be

reverse engineered.
● Accountability – Identifying the contribution of every individual involved in the
development process.
● Data Integrity – Ensuring the reliability of data.

Since the regulations of GxP are global, every company manufacturing life sciences
products is affected by it. Therefore, meeting the GxP requirements is highly
important. Though there are several GxPs, few of them are highly important for the
life cycle of any product.

1. GCP: GCP are international quality standards defined by the International

Conference on Harmonization (ICH) that state the clinical trial regulations for the
products that require testing on human subjects. The standards outline the
requirements of a clinical trial and the roles and responsibilities of the officials
 involved in it. It ensures that no human experiments are performed just for the
sake of medical advancement.

Goals of GCP:

● To protect the rights, safety and welfare of humans participating in research,

● To assure the quality, reliability and integrity of data collected,
● To provide standards and guidelines for the conduct of clinical research,
● Good Clinical Practice = Ethics + Quality Data

Principles/guidelines of ICH GCP:

GLP: defn

Importance

Principles/guidelines

GDP: defn

Importance

principles/guidelines