---
title: "Things to be aware of before continuing"
slug: "things-to-be-aware-of-before-continuing-1"
updated: 2026-10-01T21:26:20Z
published: 2026-10-01T21:26:20Z
canonical: "bgtcplaybook.document360.io/things-to-be-aware-of-before-continuing-1"
---

> ## Documentation Index
> Fetch the complete documentation index at: https://bgtcplaybook.document360.io/llms.txt
> Use this file to discover all available pages before exploring further.

# Things to be aware of before continuing

Some examples of recurrent problems that present themselves in Pre-IND meetings include [[2]](/v1/docs/ref-pre-ind-meeting):

- Clinical trial design elements in the study synopsis – e.g., unsupported or lacking rationale for starting dose, missing specific safety assessments or time points, missing data safety monitoring board review (DSMB)
- Anything less than the minimal chemical, manufacturing, and controls (CMC) information. Refer to the [Chemistry, Manufacturing, and Controls Information Summary](/v1/docs/chemistry-manufacturing-and-controls-information-summary) section for recommendations
- Anything less than the minimal toxicology and pharmacology studies to support the proof-of-concept (POC). Refer to the [Clinical Data Summaries](/v1/docs/clinical-data-summaries-1) section for recommendations
- A study design that does not comply with Good Clinical Practices (GCPs)
- Limited data supporting dose range

Now that you know the most common causes for concern, you can proceed to your Pre-IND meeting planning with the necessary information.

Data Safety Monitoring Board (DSMB) is a committee that monitors the safety of study participants and the effectiveness of the study investigational therapy [](https://toolkit.ncats.nih.gov/glossary/investigational-therapy/)during a clinical trial. Members of the disease community are often a member of a DSMB for a clinical trial for their disorder.

Chemistry, Manufacturing, and Controls (CMC) - Crucial activities when developing new pharmaceutical products. CMC involves defining manufacturing practices and product specifications that must be followed and met in order to ensure product safety and consistency between batches.

Proof of Concept (POC) - The goal of early proof of concept studies, typically involving a small number of subjects and more latitude in statistical requirements, is to provide evidence that a drug is likely to be successful in later stages of drug development. Although often not published, such studies allow drug developers to make "Go/No Go" decisions about proceeding with larger, more expensive studies.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects.