The process of getting new medicines onto the market for pharmaceutical companies is one that takes years of research and generating thousands of documents. With the best pharmaceutical documentation system, however, scientists can focus more on the research and preparation of new drugs (while automation will take care of most of the work involved in documenting findings, procedures, and everything else related to documentation). More importantly, it ensures quality control, assurance, and compliance with regulatory authorities like the FDA.
The importance of pharmaceutical documentation can’t be understated. Out of the thousands of documents needed, some stand out as key and would need to be automated. This requires creating pre-approved templates of a collection of documents.
The types of pharmaceutical documentation are divided into three stages and these include:
1- Preclinical Stage
2- Clinical Stage
3- Post Market Stage
Before clinical trials can begin, drug investigators need to carry out preparations for the tests. This involves good documentation practices in pharmaceutical industry. There are hundreds of reports and agreements that need to be created and with the help of automated pharmaceutical documentation solution, this can be achieved much faster. Here are some of the documents that need to be created:
Sometimes the investigator may decide to advertise in the media for volunteers. Having a template for these advertisements saves time. The key sections of an advertisement would be:
1. Title: The wording here may defer according to the advertiser, but it usually communicates that they are seeking volunteers to take part in a clinical trial for a particular drug.
2. Organization: The name of the organization carrying out the investigation is inserted here along with the sponsor.
3. Summary: This section provides brief information about the trial being carried out and what they intend to achieve
4. Description: This is a more detailed explanation of the study. It will introduce the problem being faced and then give details about ways to combat the disease. It may also mention the name of the trial drug. The wording in this field is entirely editable to suit the need at that time.
5. Date: Here the start date and end dates will be included.
6. Contact: This is where the investigator will insert the contact information of whoever will be in charge of receiving volunteers.
This pharmaceutical documentation is in part a letter as well as a report to the regulatory authority (FDA) requesting support and approval to begin clinical trials for a new drug. These are some sections of the application:
Application Letter: There are different types of documents in the pharmaceutical industry and this is structured like a formal letter with the name and address of the investigator at the top, the address of the regulatory body below this and the date the letter is issued. The letter should also have a title which will indicate the letter is intended to seek permission to begin testing the new drug. The body of the letter will then explain in brief the new drug and what it is believed to treat. Eventually, it will draw attention to supporting documents needed by the FDA to approve or provide support for the clinical trials. Some of the documents that need to be included are:
- Investigation Brochure
- Signed Investigation Protocol
- Informed Consent Form
- Information that the subject will be provided before they sign the consent form.
- Signed agreement between investigator and sponsor.
This document is presented to the subject (according to the pharma documentation guidelines) taking part in clinical trials and it explains to them details of the trial as well as how they will be affected. It is intended to ensure the subject understands what they are signing up for and willfully agree to be a subject in the trial. The document consists of two parts, one provides information and the other is a declaration that the subject understands the information. Sections of this document include:
1. Letter Head: This appears at the top of the page identifying the institution that is carrying out the study
2. Names: This field is for the name of the investigator and the sponsor of the research it also includes the name of the organization.
3. Introduction: This is intended to give a summary of who is conducting the research, why it is being carried out, and what the trial involves. It is partly the same information already provided at the top as well as some of what they will read in other sections.
4. Research purpose: Here the template provides a short insight into the problem that the research intends to solve. The language here needs to be simple and straight to the point so that the subject is enlightened and not confused.
5. Type of Research: This section of the pharmaceutical documentation PDF provides clarification about how the trial will be carried out. For example, through oral administering of a drug, injection, or even questionnaire. More about the procedure will be included in other sections.
6. Subject Selection: The section explains the criteria for choosing a subject and informs the subject why they are the right person to take part in the trial.
7. Voluntary Involvement: This paragraph will explain what is considered as voluntary participation and the subject is informed about their right to exit the trial at any point.
8. Drug Information: The subject needs to know everything about the drug, right from its name to the possible side effects of taking it as well as possible outcomes of the trial.
9. Procedure and Protocol: This is a detailed section according to the latest pharmaceutical guidelines that explains in clear terms what will be done and how it will be done. Unfamiliar terms and procedures are given extra attention to ensure they are clear to the subject. This will include fields that indicate the duration of the trial, risks associated, benefits as well as reimbursement.
10. Confidentiality: This section explains the duty they will have to keep certain information confidential as well as the duty the investigator has to keep their information confidential. It, however, also points out that research findings may be shared with many other parties.
11. Reassurance: This part is intended to provide information that can reassure a participant of their freedom to leave the trial, participate in an alternative capacity as well as consult someone in case they have any issues that need resolving. A paragraph may also be included explaining that the research is approved by the regulatory body and their safety is taken seriously.
12. Declaration: This is the second part of the informed consent template. It is a brief statement to the effect that the subject has understood the implications of taking part and freely provided consent to be used as stated in the protocol. (More information about the declaration template can be seen under “Informed Consent” document in Clinical Stage Templates.
In the preclinical trial stage, different parties need to work together to achieve the common goal. These parties will sign contracts or memorandums that acknowledge their willingness to be a part of the trials and sign the pharmaceutical documentation. Regulatory bodies would need to see some of these contracts especially between the investigator and the sponsor, as well as between the investigator and the subject. The general template for a contract would have the following sections:
1. Heading: This field describes the document heading which is usually short and precise.
2. Introduction: This segment of the document describes the purpose of the contract. It includes information like the parties involved and what they are agreeing about. It can also give details about each party like full names, the organization, and address. The date the agreement is being made will also be included.
3. Scope: This gives broad statements about the kind of contract being entered into.
4. Roles: Here the parties involved are assigned roles in the project they are about to undertake. A field is created where the names of the parties will be inserted, followed by the role they will play. In the case of the sponsor, the name may be of the organization facilitating the trials.
5. Terms and Conditions: This section describes what each party needs to fulfill for the contract to be enforced. There is also a field that includes the duration of the collaboration. There is also a field that provides for amendment of conditions. Reference may also be made to parts of the clinical study protocol which may have more detailed procedures to be followed.
6. Declaration: This area has fields where the parties involved will append their signatures to show they agree to the terms set in the contract.
This is the stage where the researchers test to see if a drug is safe and what effects it may have when administered to a subject. Pharmaceutical documentation produced at this stage are shared among peers as well as with pharma regulatory compliance bodies like FDA. The report templates that need to be produced include the following:
This document contains all the necessary information needed to conduct the clinical trials. The information here needs to be concise, balanced, and objective. The sections include:
1. Title Page: This is the cover of the document and has fields for:
- Identity of product
- Name of sponsor
- Brochure edition number and date
- Confidentiality statement
2. Descriptions: This is the next page that contains abbreviations and descriptions of words that may not be familiar.
3. Content: Here, a list of page numbers and chapters with their headings is included.
4. Summary: It is a section that describes the drug. It contains brief descriptions of its physical, chemical, and pharmacological characteristics. The researchers can choose what extra information is necessary to include here based on what they know from preclinical studies.
5. Introduction: This part of the document has fields for description of the drug by its chemical name as well as trade name if that has been approved. There is also a field that captures all the active ingredients as well as justification for performing more tests. It also summarizes the procedure to be followed in the investigation.
6. Non-Clinical Studies: Here’s where information about animal trials is recorded. It has fields that will capture information like pharmacological, metabolic, toxicology, and pharmacokinetic effects of the drug.
7. Clinical Studies: This section captures data on human trials of the drug. It has fields for safety data, efficacy, biotransformation, and everything that is noted about the drug’s interaction with humans.
8. Conclusion: This is where the researcher’s findings will be provided with advice and guidance on the use of the drug.
9. Reference: Reference information is usually included at the end of each section.
This document contains guidelines for every person involved in the clinical study. It is a sort of rulebook for the study but needs to be as detailed as possible. Pharmaceutical document automation can ensure that nothing gets left out. The template contains the following sections:
1. Introduction: The fields here are intended to give a brief description of the ailments and the treatment procedure to be followed.
2. Objectives: This field describes what the study intends to achieve.
3. Duration: Here the start date of the study and the end date will be indicated
4. Subjects: This field will contain the number of subjects.
5. Informed Consent: This is a brief statement about the section that will be included in the document.
6. Ethics Committee Opinion: A brief statement from the Ethics Committee about the trials being carried out.
7. Subject Selection: This field will list what was considered when choosing subjects to take part in the study. It will also have fields for criteria for inclusion and exclusion.
8. Methodology: Here is a section that may take up a single page or several pages. There are a number of fields that include, the study plan, schedule, procedures to be followed, what defines efficacy of the drug as well as endpoints. There is also a field for treatment cycles.
9. Safety Reporting: This section is of critical interest to regulatory bodies and must be a part of quality assurance documents submitted by the pharmaceutical company. The fields that are included include adverse events (both serious and minor), questionable lab test values, irregular safety parameters, and extraction from the study.
10. Clinical Laboratory Parameters: In this part, observations made will be recorded here, the kind of changes that will be recorded are defined in this section.
11. Additional Safety Parameters: This area explains any safety parameters that are added to the trial.
12. Concomitant Medication: This will include any medications that are given to the subject along with the test medication.
13. Data Analysis: The way data will be analyzed is explained in this section
14. Approval: The committee will sign approval of this document. A field can be added for the signature while approval notes can be part of the template.
This is a form on which the subject gives their consent to be part of the study. The subject needs to know everything about the study and how it will affect them. The template for this pharmaceutical documentation would include:
1. Subjects Details: A field is created for the insertion of the subject’s name, address, age, gender, and all-important personal information.
2. Definition: This section defines the document as an informed consent form and describes the test being carried out.
3. Declaration: The subject’s declaration of informed consent will be in this section. The declaration is usually to the effect that the subject understands the purpose of the trial, the method, the options available, the drugs being tested, and possible side effects. There should also be an indication that the subject gave consent out of free will and they can withdraw from the trial at any point without any consequences. There will also be a field for the subject to sign.
Every part of the study needs to be documented. These small progress reports will help in compiling the complete clinical trial report. Study progress reports could be written daily or whenever there is an even to report. This means templates need to be created according to the progress reports that will be written.
This is a pharma document that captures all the information about the subject which will be necessary for use in the study protocol. It is designed as a form with the following fields:
- Trial title and number
- Name of investigator
- ID number of the subject
- Subjects’ personal information
- Criteria for inclusion and exclusion
- Drug regimen to be followed
- Adverse events
- Diagnosis of the subject’s health
- Signature of investigator
- The date the form was signed
The post-market stage of pharmaceutical documentation is mainly about following up on the safety of the drug that has been put on the market (pharmacovigilance). The main concern is about capturing reports of adverse events and then analyzing the compiled data to come up with a report. The templates created for this purpose help in capturing data. These templates would include the following fields:
1. Medication Name: This would comprise its trade name and generic name
2. Location: This section captures the location where the adverse reaction is being reported
3. Demographic: There are a series of fields in this section to capture demographic information like age, gender, weight, race, and so on.
4. Adverse Event: Here the adverse event is described. The template could have multiple options with a checkbox to tick which adverse event occurred. Another field can be provided to note down an effect that may not be included in the options.
5. Dosage: The amount of the drug taken needs to be indicated as well as what had been prescribed.
6. Other Medication: This field captures any other medications that the subject may have been taking at the same time.
7. Medical History: The subject who has experienced adverse reactions needs to be researched on as well so any information regarding past reactions may need to be recorded. There can also be a field with tick boxes besides common conditions known to react to the composition of the medication. For example, pregnancy, hypertension, heart problems, and so on.
8. Final Report: All the information captured in the template is compiled into a final report using document automation software. This report can be analyzed and used to compile another report on the safety of the drug.
In conclusion, good documentation practices in pharmaceutical industry will ensure that your drug or vaccine development process from the preclinical to post market happens seamlessly. You can ensure the quality and safety aspects of the whole process is well documented and submitted to regulatory bodies for quicker approvals.